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    Summary
    EudraCT Number:2010-022164-12
    Sponsor's Protocol Code Number:TOG301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prohibited by CA
    Date on which this record was first entered in the EudraCT database:2011-08-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2010-022164-12
    A.3Full title of the trial
    A randomized, double-blind study of capecitabine plus
    tesetaxel versus capecitabine plus placebo as second-line
    therapy in subjects with gastric cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tesetaxel, an oral taxane, and capecitabine versus placebo and capecitabine in gastric cancer
    A.4.1Sponsor's protocol code numberTOG301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenta Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGenta Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenta Incorporated
    B.5.2Functional name of contact pointGenta Medical Information
    B.5.3 Address:
    B.5.3.1Street Address200 Connell Drive
    B.5.3.2Town/ cityBerkeley Heights, NJ
    B.5.3.3Post code07922
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908286-3113
    B.5.5Fax number+1908464-9353
    B.5.6E-mailmedinfo@genta.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/829
    D.3 Description of the IMP
    D.3.1Product nameTesetaxel 5
    D.3.2Product code DJ-927
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTesetaxel
    D.3.9.2Current sponsor codeDJ-927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/829
    D.3 Description of the IMP
    D.3.1Product nameTesetaxel 10
    D.3.2Product code DJ-927
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTesetaxel
    D.3.9.2Current sponsor codeDJ-927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10017760
    E.1.2Term Gastric cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of capecitabine plus tesetaxel (capecitabine-tesetaxel) versus capecitabine plus placebo (capecitabine-placebo) as second-line therapy in subjects with gastric cancer
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age
    2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma. (Histologically confirmed adenocarcinoma of the lower esophagus is acceptable if there is radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)
    3. Measurable disease (revised RECIST) version 1.1. based on computed tomography, or nonmeasurable disease
    4. Eastern Cooperative Oncology Group performance status 0 or 1
    5. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent
    N.B. Prior adjuvant or neo-adjuvant chemotherapy is acceptable provided that 6 months elapsed between the end of the adjuvant or neoadjuvant therapy and the start of first-line therapy.
    N.B. If disease progression is documented within 2 months after the end of adjuvant or neoadjuvant chemotherapy with a fluoropyrimidine and a platinum-containing agent, that adjuvant or neoadjuvant chemotherapy will be considered first-line therapy.
    6. Disease progression after the start of the 1 prior regimen based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium)
    N.B. Residual disease that is documented within 2 months after the end of adjuvant or neoadjuvent chemotherapy with a fluoropyrimidine and a platinum-containing agent will be considered disease progression.
    7. Adequate bone marrow, hepatic, and renal function, as evidenced by:
    a. Absolute neutrophil count (ANC) at least 1500/mm3
    b. Platelet count at least 100,000/mm3
    c. Hemoglobin >= 10 g/dL without the need for hemotopoietic growth factor or transfusion support
    d. Aspartate aminotransferase ≤ 1.5 times the upper limit of normal (x ULN) or, in the presence of liver metastasis, ≤ 2.5 x ULN
    e. Alanine aminotransferase ≤ 1.5 x ULN or, in the presence of liver metastasis, ≤ 2.5 x ULN
    f. Total bilirubin within the normal range except in the presence of Gilbert's disease. N.B. In subjects with Gilbert's diseae, contact the Genta Medical Monitor prior to enrollment.
    g. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearence not less than 50 mL/min based on the Cockcroft-Gault formula. (See appendix B of protocol for further information)
    8. At least 3 weeks and recovery from effects of prior major surgery or radiation therapy
    9. If previously administered as treatment for gastric cancer, prior to study entry a washout period equivalent to at least 5 half-lives for antibodies and of at least 21 days for chemotherapy (Concurrent use of bisphosphonates is permitted.)
    10. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present.
    11. A negative serum pregnancy test within 7 days prior to randomization in women of childbearing potential (that is, all women except those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization)
    12. Agreement to use an effective form of contraception (ie, one that has a failure rate of < 1%) throughout the treatment phase of the study in women of childbearing potential (that is, all women except those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization) and sexually active men.
    13. All participating countries except France: Written informed consent and authorization to use and disclose health information. In France only: Signed written informed consent.
    14. Ability to comprehend and to comply with the requirements of the study.
    15. In France only: Affiliated with social security.
    E.4Principal exclusion criteria
    1.Squamous cell gastric carcinoma
    2.Bone-only metastatic disease
    3. History or presence of brain metastasis or leptomeningeal disease
    4. Operable gastric or gastroesophageal-junction cancer
    5. HER2-positive disease if the subject has not previously been treated with an anti-HER2 agent
    6. Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject’s usual number of bowel movements on at least 3 days within the 14 days prior to randomization
    7. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to randomization despite the administration of standard antiemetic therapy
    8. Known malabsorptive disorder
    9. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
    10. Human immunodeficiency virus infection based on history of positive serology
    11. Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
    12. Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria; Version 4.0)
    13. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)
    14. Prior radiation therapy to more than 25% of the bone marrow
    15. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy
    16. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
    17. Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway
    18. History of severe or unexpected reaction to fluoropyrimidine therapy.
    19. History of hypersensitivity to capecitabine, other fluoropyrimidine agents or any of their ingredients.
    20. Known dihydropyrimidine dehydrogenase deficiency
    21. Pregnancy or lactation
    22.Participation in another clinical trial in which an investigational agent is required to be administered during the treatment phase of study TOG301
    23. In France only: Being of full age under legal protection or being deprived of liberty
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    When at least 508 events (deaths) have occurred which is estimated will occur 12 months after the date of randomization of the last subject
    E.5.2Secondary end point(s)
    Efficacy
    Secondary efficacy endpoints include:
    • the percentages of subjects with disease control (complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization [the disease control rate]). (Complete response, partial response, and stable disease are as defined in the revised Response Evaluation Criteria in Solid Tumors [RECIST].) Version 1.1
    • progression-free survival
    • point estimates of overall survival every 6 months for up to 24 months from the date of randomization
    For exploratory purposes, the following will be calculated only in subjects with measurable disease:
    • the percentage of subjects with response (complete or partial response [the response rate]) (RECIST) version 1.1
    • the percentage of subjects with durable response (complete or partial response at least 6 months in duration [the durable response rate])
    Safety
    • adverse events
    • changes in clinical laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time of the analysis of the primary end point
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    China
    France
    Germany
    Italy
    Korea, Republic of
    Spain
    Taiwan
    United States
    E.8.7Trial 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
    12 months from date of randomization of the last subject plus 30 days if the last subject receives 12 months of treatment
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 580
    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)
    Participation in a separate extension study in which eligible patients will continue the same treatment as administered in Study TOG301
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-23
    P. End of Trial
    P.End of Trial StatusProhibited by CA
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