Summary
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EudraCT Number: | 2016-000816-14 |
Sponsor's Protocol Code Number: | CO-338-043 |
National Competent Authority: | Czechia - SUKL |
Clinical Trial Type: | EEA CTA |
Trial Status: | Completed |
Date on which this record was first entered in the EudraCT database: | 2016-10-07 |
Trial results | View results |
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A. Protocol Information
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A.1 | Member State Concerned | Czechia - SUKL | ||||
A.2 | EudraCT number | 2016-000816-14 | ||||
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 | CO-338-043 | ||||
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 | Clovis Oncology, 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 | Clovis Oncology, 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 | Clovis Oncology UK Ltd |
B.5.2 | Functional name of contact point | Chief Medical Officer |
B.5.3 | Address: | |
B.5.3.1 | Street Address | Granta Centre, Granta Park, Great Abington |
B.5.3.2 | Town/ city | Cambridge |
B.5.3.3 | Post code | CB21 6GP |
B.5.3.4 | Country | United Kingdom |
B.5.4 | Telephone number | +441223 645500 |
B.5.5 | Fax number | +441223 281 382 |
B.5.6 | info@clovisoncology.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.2.1.1.1 | Trade name | Rubraca 200 mg film-coated tablets |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Clovis Oncology Ireland Ltd. |
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 | Rucaparib |
D.3.2 | Product code | CO-338 |
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 | Rucaparib camsylate |
D.3.9.1 | CAS number | 283173-50-2 |
D.3.9.2 | Current sponsor code | CO-338 |
D.3.9.3 | Other descriptive name | RUCAPARIB |
D.3.9.4 | EV Substance Code | SUB74859 |
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 | 200 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | Rubraca 250 mg film coated tablets |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Clovis Oncology Ireland Ltd. |
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 | Rucaparib |
D.3.2 | Product code | CO-338 |
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 | Rucaparib camsylate |
D.3.9.1 | CAS number | 283173-50-2 |
D.3.9.2 | Current sponsor code | CO-338 |
D.3.9.3 | Other descriptive name | RUCAPARIB |
D.3.9.4 | EV Substance Code | SUB74859 |
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 | 250 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | Rubraca 300 mg film-coated tablets |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Clovis Oncology Ireland Ltd. |
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 | Rucaparib |
D.3.2 | Product code | CO-338 |
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 | Rucaparib camsylate |
D.3.9.1 | CAS number | 283173-50-2 |
D.3.9.2 | Current sponsor code | CO-338 |
D.3.9.3 | Other descriptive name | RUCAPARIB |
D.3.9.4 | EV Substance Code | SUB74859 |
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 | 300 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Carboplatin 10 mg/ml Intravenous Infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Hospira UK Ltd |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Carboplatin |
D.3.4 | Pharmaceutical form | Solution for infusion |
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 | Carboplatin |
D.3.9.3 | Other descriptive name | CARBOPLATIN |
D.3.9.4 | EV Substance Code | SUB06614MIG |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Cisplatin 1 mg/ml Sterile Concentrate |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Hospira UK Ltd |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Cisplatin |
D.3.4 | Pharmaceutical form | Concentrate for solution for infusion |
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 | CISPLATIN |
D.3.9.3 | Other descriptive name | CISPLATIN |
D.3.9.4 | EV Substance Code | SUB07483MIG |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Paclitaxel 6mg/ml concentrate for solution for infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Hospira UK Ltd |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Paclitaxel |
D.3.4 | Pharmaceutical form | Concentrate for solution for infusion |
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 | PACLITAXEL |
D.3.9.1 | CAS number | 33069-62-4 |
D.3.9.4 | EV Substance Code | SUB09583MIG |
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 | 6 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Gemcitabine 1000mg powder for solution for infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Sun Pharmaceutical Industries Europe B.V. |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Gemcitabine |
D.3.4 | Pharmaceutical form | Powder for solution for infusion |
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 | GEMCITABINE |
D.3.9.1 | CAS number | 95058-81-4 |
D.3.9.4 | EV Substance Code | SUB07892MIG |
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 | 1000 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Carboplatin Bendalis 10 mg/ml, concentrate for solution for infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Bendalis 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 | Carboplatin |
D.3.4 | Pharmaceutical form | Solution for infusion |
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 | Carboplatin |
D.3.9.3 | Other descriptive name | CARBOPLATIN |
D.3.9.4 | EV Substance Code | SUB06614MIG |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | NeoCorp Cisplatin 1 mg/ml concentrate for solution for infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Hexal AG |
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 | Cisplatin |
D.3.4 | Pharmaceutical form | Concentrate for solution for infusion |
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 | CISPLATIN |
D.3.9.3 | Other descriptive name | CISPLATIN |
D.3.9.4 | EV Substance Code | SUB07483MIG |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Paclitaxel 6mg/ml Solution for Injection |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Hospira Health Care Corporation, US |
D.2.1.2 | Country which granted the Marketing Authorisation | United States |
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 | Paclitaxel 6mg/ml Solution for Injection |
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 | PACLITAXEL |
D.3.9.1 | CAS number | 33069-62-4 |
D.3.9.4 | EV Substance Code | SUB09583MIG |
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 | 6 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | Taxomedac – Paclitaxel 6 mg/mL Concentrate for Solution for Infusion 100 mg |
D.2.1.1.2 | Name of the Marketing Authorisation holder | medac Gesellschaft für klinische Spezialpräparate m.b.H, Germany |
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 | Taxomedac 6 mg/mL, concentrate for solution for infusion |
D.3.4 | Pharmaceutical form | Concentrate for solution for infusion |
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 | PACLITAXEL |
D.3.9.1 | CAS number | 33069-62-4 |
D.3.9.4 | EV Substance Code | SUB09583MIG |
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 | 6 |
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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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] - Cancer [C04] | |||||||||||||||
MedDRA Classification | |||||||||||||||||
E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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E.1.3 | Condition being studied is a rare disease | No | |||||||||||||||
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 | No | |||||||||||||||
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 | No | |||||||||||||||
E.6.10 | Pharmacogenetic | No | |||||||||||||||
E.6.11 | Pharmacogenomic | No | |||||||||||||||
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 | Yes | |||||||||||||||
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 | 4 | |||||||||||||||
E.8.5 | The trial involves multiple Member States | Yes | |||||||||||||||
E.8.5.1 | Number of sites anticipated in the EEA | 38 | |||||||||||||||
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 | No | |||||||||||||||
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 | 4 | |||||||||||||||
E.8.9.1 | In the Member State concerned months | 7 | |||||||||||||||
E.8.9.1 | In the Member State concerned days | 0 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial years | 5 | |||||||||||||||
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
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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: | 310 | |
F.1.3 | Elderly (>=65 years) | Yes | |
F.1.3.1 | Number of subjects for this age range: | 35 | |
F.2 Gender | |||
F.2.1 | Female | Yes | |
F.2.2 | Male | No | |
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 | 16 | |
F.4.2 | For a multinational trial | ||
F.4.2.2 | In the whole clinical trial | 345 | |
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) |
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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
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N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2017-01-17 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
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N. | Date of Ethics Committee Opinion | 2016-12-08 |
P. End of Trial
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P. | End of Trial Status | Completed |