Tesetaxel, an oral taxane, and capecitabine versus placebo and capecitabine in gastric cancer

• Conditions: Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma; MedDRA version: 14.1Level: LLTClassification code 10017760Term: Gastric cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022164-12-DE
• Lead Sponsor: Genta Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 580

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 Fra

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified