Gastric Carcinoma
Conditions
Brief summary
This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.
Interventions
DRUGTesetaxel
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
DRUGPlacebo
Placebo orally once on Day 1 of each cycle
DRUGCapecitabine
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
Sponsors
Genta Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: 1. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.) 2. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease 3. ECOG performance status 0 or 1 4. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.) 5. Disease progression after the start of the 1 prior regimen based on computed tomography 6. Adequate bone marrow, hepatic, and renal function 7. Ability to swallow an oral solid-dosage form of medication Key
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 patient has not previously been treated with an anti-HER2 agent 6. Uncontrolled diarrhea, nausea, or vomiting 7. Known malabsorptive disorder 8. Significant medical disease other than gastric cancer 9. Presence of neuropathy \> Grade 1 (NCI Common Toxicity Criteria) 10. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.) 11. Prior radiation therapy to more than 25% of the bone marrow 12. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway 13. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | Estimated will be assessed 12 months after the date of randomization of the last patient | The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST) |
| Progression-free survival | Estimated will be assessed 12 months after the date of randomization of the last patient | Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment |
| Response rate in patients with measurable disease | Estimated will be assessed 12 months after the date of randomization of the last patient | The percentages of patients with complete or partial response (revised RECIST) |
| Incidence of adverse events | Through 30 days after the last dose of study medication | The percentages of patients who experience adverse events by specific adverse event term |
Countries
Germany, Taiwan, United States
Contacts
Primary ContactMansoor Ahmad, MD, PhD
Outcome results
None listed