Summary
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EudraCT Number: | 2018-000397-30 |
Sponsor's Protocol Code Number: | Ponatinib-3001 |
National Competent Authority: | Italy - Italian Medicines Agency |
Clinical Trial Type: | EEA CTA |
Trial Status: | Trial now transitioned |
Date on which this record was first entered in the EudraCT database: | 2021-01-22 |
Trial results |
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A. Protocol Information
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A.1 | Member State Concerned | Italy - Italian Medicines Agency | ||||
A.2 | EudraCT number | 2018-000397-30 | ||||
A.3 | Full title of the trial |
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A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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A.3.2 | Name or abbreviated title of the trial where available |
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A.4.1 | Sponsor's protocol code number | Ponatinib-3001 | ||||
A.5.2 | US NCT (ClinicalTrials.gov registry) number | NCT03589326 | ||||
A.5.3 | WHO Universal Trial Reference Number (UTRN) | U1111-1206-2370 | ||||
A.5.4 | Other Identifiers |
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A.7 | Trial is part of a Paediatric Investigation Plan | No | ||||
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | MILLENNIUM PHARMACEUTICALS, INC. |
B.1.3.4 | Country | United States |
B.3.1 and B.3.2 | Status of the sponsor | Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | Millennium Pharmaceuticals, Inc. |
B.4.2 | Country | United States |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | Millennium Pharmaceuticals, Inc. |
B.5.2 | Functional name of contact point | Drug Information Call Center |
B.5.3 | Address: | |
B.5.3.1 | Street Address | 40 Lansdowne St |
B.5.3.2 | Town/ city | Cambridge |
B.5.3.3 | Post code | 02139 |
B.5.3.4 | Country | United States |
B.5.4 | Telephone number | 0015107402412 |
B.5.5 | Fax number | 0018008816092 |
B.5.6 | medical@mlnm.com |
D. IMP Identification
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D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ponatinib |
D.3.2 | Product code | [AP24534] |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | PONATINIB |
D.3.9.1 | CAS number | 943319-70-8 |
D.3.9.2 | Current sponsor code | Ponatinib |
D.3.9.3 | Other descriptive name | PONATINIB |
D.3.9.4 | EV Substance Code | SUB91901 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 15 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Cellcristin® 1 mg/ml Injektionslösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | STADAPHARM GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | cellcristin® 1 mg/ml Injektionslösung |
D.3.2 | Product code | [Vincristina] |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | VINCRISTINA |
D.3.9.1 | CAS number | 57-22-7 |
D.3.9.2 | Current sponsor code | Vincristine |
D.3.9.3 | Other descriptive name | Vincristine |
D.3.9.4 | EV Substance Code | SUB00059MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 3 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Methotrexat-GRY® 5000 mg/50 ml Konzentrat zur Herstellung einer Infusionslösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | TEVA GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Methotrexat-GRY® |
D.3.2 | Product code | [Metotressato] |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | METOTREXATO |
D.3.9.1 | CAS number | 59-05-2 |
D.3.9.2 | Current sponsor code | Methotrexate |
D.3.9.3 | Other descriptive name | Methotrexate |
D.3.9.4 | EV Substance Code | SUB08856MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 4 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Calciumfolinat-GRY® 15 mg Tabletten |
D.2.1.1.2 | Name of the Marketing Authorisation holder | TEVA GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Calciumfolinat |
D.3.2 | Product code | [Calciumfolinat] |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | CALCIO FOLINATO |
D.3.9.1 | CAS number | 1492-18-8 |
D.3.9.2 | Current sponsor code | Folinic Acid |
D.3.9.3 | Other descriptive name | Folinic Acid |
D.3.9.4 | EV Substance Code | SUB13910MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 15 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 5 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Dexamethasone Krka |
D.2.1.1.2 | Name of the Marketing Authorisation holder | KRKA |
D.2.1.2 | Country which granted the Marketing Authorisation | Poland |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Desametasone |
D.3.2 | Product code | [Desametasone] |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | DESAMETASONE |
D.3.9.1 | CAS number | 50-02-2 |
D.3.9.2 | Current sponsor code | Dexamethasone |
D.3.9.3 | Other descriptive name | Dexamethasone |
D.3.9.4 | EV Substance Code | SUB07017MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 20 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 6 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Alexan |
D.2.1.1.2 | Name of the Marketing Authorisation holder | EBEWE Pharma Ges.m.b.H. Nfg. |
D.2.1.2 | Country which granted the Marketing Authorisation | Poland |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Citarabina |
D.3.2 | Product code | [Citarabina] |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | CITARABINA |
D.3.9.1 | CAS number | 147-94-4 |
D.3.9.2 | Current sponsor code | Cytarabine |
D.3.9.3 | Other descriptive name | Cytarabine |
D.3.9.4 | EV Substance Code | SUB06880MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 7 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ponatinib |
D.3.2 | Product code | [AP24534] |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | PONATINIB |
D.3.9.1 | CAS number | 943319-70-8 |
D.3.9.2 | Current sponsor code | Ponatinib |
D.3.9.3 | Other descriptive name | Ponatinib |
D.3.9.4 | EV Substance Code | SUB91901 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 45 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 8 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Prednison 50 mg GALEN Tabletten |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GALENpharma GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Prednison 50 mg GALEN Tabletten |
D.3.2 | Product code | [Prednisone] |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | PREDNISONE |
D.3.9.1 | CAS number | 53-03-2 |
D.3.9.2 | Current sponsor code | Prednisone |
D.3.9.3 | Other descriptive name | Prednisone |
D.3.9.4 | EV Substance Code | SUB10020MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 9 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Glivec |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Novartis Europharm Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Imatinib |
D.3.2 | Product code | [STI571] |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | IMATINIB MESILATO |
D.3.9.1 | CAS number | 152459-95-5 |
D.3.9.2 | Current sponsor code | Imatinib |
D.3.9.3 | Other descriptive name | IMATINIB |
D.3.9.4 | EV Substance Code | SUB25387 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 400 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 10 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Dexagalen® 4mg injekt, Injektionslösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GALENpharma GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Dexagalen® 4mg injekt, Injektionslösung |
D.3.2 | Product code | [Desametasone] |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | DESAMETASONE |
D.3.9.1 | CAS number | 50-02-2 |
D.3.9.2 | Current sponsor code | DEXAMETHASONE |
D.3.9.3 | Other descriptive name | DEXAMETHASONE |
D.3.9.4 | EV Substance Code | SUB07017MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 11 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ponatinib |
D.3.2 | Product code | [AP24534] |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | PONATINIB |
D.3.9.1 | CAS number | 943319-70-8 |
D.3.9.2 | Current sponsor code | Ponatinib |
D.3.9.3 | Other descriptive name | PONATINIB |
D.3.9.4 | EV Substance Code | SUB91901 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 12 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Calciumfolinat-GRY® 100 mg/10 ml Injektionslösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | TEVA GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Calciumfolinat-GRY® 100 mg/10 ml Injektionslösung |
D.3.2 | Product code | [Calciumfolinat] |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | CALCIO FOLINATO |
D.3.9.1 | CAS number | 1492-18-8 |
D.3.9.2 | Current sponsor code | Folinic Acid |
D.3.9.3 | Other descriptive name | Folinic Acid |
D.3.9.4 | EV Substance Code | SUB13910MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 13 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Glivec |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Novartis Europharm Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Imatinib |
D.3.2 | Product code | [STI571] |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | IMATINIB MESILATO |
D.3.9.1 | CAS number | 152459-95-5 |
D.3.9.2 | Current sponsor code | Imatinib |
D.3.9.3 | Other descriptive name | Imatinib |
D.3.9.4 | EV Substance Code | SUB25387 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.8 Information on Placebo
|
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E. General Information on the Trial
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E.1 Medical condition or disease under investigation | ||||||||||||||||||||||
E.1.1 | Medical condition(s) being investigated |
|
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E.1.1.1 | Medical condition in easily understood language |
|
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] | ||||||||||||||||||||
MedDRA Classification | ||||||||||||||||||||||
E.1.2 Medical condition or disease under investigation | ||||||||||||||||||||||
|
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E.1.3 | Condition being studied is a rare disease | Yes | ||||||||||||||||||||
E.2 Objective of the trial | ||||||||||||||||||||||
E.2.1 | Main objective of the trial |
|
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No | ||||||||||||||||||||
E.3 | Principal inclusion criteria |
|
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E.4 | Principal exclusion criteria |
|
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E.5 End points | ||||||||||||||||||||||
E.5.1 | Primary end point(s) |
|
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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E.6 and E.7 Scope of the trial | ||||||||||||||||||||||
E.6 | Scope of the trial | |||||||||||||||||||||
E.6.1 | Diagnosis | No | ||||||||||||||||||||
E.6.2 | Prophylaxis | No | ||||||||||||||||||||
E.6.3 | Therapy | Yes | ||||||||||||||||||||
E.6.4 | Safety | Yes | ||||||||||||||||||||
E.6.5 | Efficacy | Yes | ||||||||||||||||||||
E.6.6 | Pharmacokinetic | Yes | ||||||||||||||||||||
E.6.7 | Pharmacodynamic | No | ||||||||||||||||||||
E.6.8 | Bioequivalence | No | ||||||||||||||||||||
E.6.9 | Dose response | Yes | ||||||||||||||||||||
E.6.10 | Pharmacogenetic | No | ||||||||||||||||||||
E.6.11 | Pharmacogenomic | Yes | ||||||||||||||||||||
E.6.12 | Pharmacoeconomic | No | ||||||||||||||||||||
E.6.13 | Others | No | ||||||||||||||||||||
E.7 | Trial type and phase | |||||||||||||||||||||
E.7.1 | Human pharmacology (Phase I) | No | ||||||||||||||||||||
E.7.1.1 | First administration to humans | No | ||||||||||||||||||||
E.7.1.2 | Bioequivalence study | No | ||||||||||||||||||||
E.7.1.3 | Other | No | ||||||||||||||||||||
E.7.1.3.1 | Other trial type description | |||||||||||||||||||||
E.7.2 | Therapeutic exploratory (Phase II) | No | ||||||||||||||||||||
E.7.3 | Therapeutic confirmatory (Phase III) | Yes | ||||||||||||||||||||
E.7.4 | Therapeutic use (Phase IV) | No | ||||||||||||||||||||
E.8 Design of the trial | ||||||||||||||||||||||
E.8.1 | Controlled | Yes | ||||||||||||||||||||
E.8.1.1 | Randomised | Yes | ||||||||||||||||||||
E.8.1.2 | Open | Yes | ||||||||||||||||||||
E.8.1.3 | Single blind | No | ||||||||||||||||||||
E.8.1.4 | Double blind | No | ||||||||||||||||||||
E.8.1.5 | Parallel group | Yes | ||||||||||||||||||||
E.8.1.6 | Cross over | No | ||||||||||||||||||||
E.8.1.7 | Other | No | ||||||||||||||||||||
E.8.2 | Comparator of controlled trial | |||||||||||||||||||||
E.8.2.1 | Other medicinal product(s) | Yes | ||||||||||||||||||||
E.8.2.2 | Placebo | No | ||||||||||||||||||||
E.8.2.3 | Other | No | ||||||||||||||||||||
E.8.2.4 | Number of treatment arms in the trial | 2 | ||||||||||||||||||||
E.8.3 | The trial involves single site in the Member State concerned | No | ||||||||||||||||||||
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes | ||||||||||||||||||||
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 | ||||||||||||||||||||
E.8.5 | The trial involves multiple Member States | Yes | ||||||||||||||||||||
E.8.5.1 | Number of sites anticipated in the EEA | 37 | ||||||||||||||||||||
E.8.6 Trial involving sites outside the EEA | ||||||||||||||||||||||
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes | ||||||||||||||||||||
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT | ||||||||||||||||||||
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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E.8.7 | Trial has a data monitoring committee | Yes | ||||||||||||||||||||
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial |
|
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E.8.9 Initial estimate of the duration of the trial | ||||||||||||||||||||||
E.8.9.1 | In the Member State concerned years | 7 | ||||||||||||||||||||
E.8.9.1 | In the Member State concerned months | 9 | ||||||||||||||||||||
E.8.9.1 | In the Member State concerned days | 0 | ||||||||||||||||||||
E.8.9.2 | In all countries concerned by the trial years | 8 | ||||||||||||||||||||
E.8.9.2 | In all countries concerned by the trial months | 0 | ||||||||||||||||||||
E.8.9.2 | In all countries concerned by the trial days | 0 |
F. Population of Trial Subjects
|
||||
---|---|---|---|---|
F.1 Age Range | ||||
F.1.1 | Trial has subjects under 18 | No | ||
F.1.1.1 | In Utero | No | ||
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No | ||
F.1.1.3 | Newborns (0-27 days) | No | ||
F.1.1.4 | Infants and toddlers (28 days-23 months) | No | ||
F.1.1.5 | Children (2-11years) | No | ||
F.1.1.6 | Adolescents (12-17 years) | No | ||
F.1.2 | Adults (18-64 years) | Yes | ||
F.1.2.1 | Number of subjects for this age range: | 272 | ||
F.1.3 | Elderly (>=65 years) | Yes | ||
F.1.3.1 | Number of subjects for this age range: | 48 | ||
F.2 Gender | ||||
F.2.1 | Female | Yes | ||
F.2.2 | Male | Yes | ||
F.3 Group of trial subjects | ||||
F.3.1 | Healthy volunteers | No | ||
F.3.2 | Patients | Yes | ||
F.3.3 | Specific vulnerable populations | Yes | ||
F.3.3.1 | Women of childbearing potential not using contraception | No | ||
F.3.3.2 | Women of child-bearing potential using contraception | Yes | ||
F.3.3.3 | Pregnant women | No | ||
F.3.3.4 | Nursing women | No | ||
F.3.3.5 | Emergency situation | No | ||
F.3.3.6 | Subjects incapable of giving consent personally | No | ||
F.3.3.7 | Others | No | ||
F.4 Planned number of subjects to be included | ||||
F.4.1 | In the member state | 40 | ||
F.4.2 | For a multinational trial | |||
F.4.2.1 | In the EEA | 123 | ||
F.4.2.2 | In the whole clinical trial | 320 | ||
F.5 | Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) |
|
G. Investigator Networks to be involved in the Trial
|
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N. Review by the Competent Authority or Ethics Committee in the country concerned
|
||
---|---|---|
N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2019-01-14 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
N. | Date of Ethics Committee Opinion | 2019-02-07 |
P. End of Trial
|
||
---|---|---|
P. | End of Trial Status | Trial now transitioned |