Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer (TESEGAST)

Genta Incorporated

Status and phase: Unknown; Phase 2

Conditions: Gastric Carcinoma

Treatments: Drug: Placebo; Drug: Tesetaxel; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573468

TOG301

2010-022164-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 580 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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580 participants in 2 patient groups

Capecitabine-tesetaxel

Experimental group

Description:

21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14

Treatment:

Drug: Capecitabine

Drug: Tesetaxel

Capecitabine-placebo

Active Comparator group

Description:

21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14

Treatment:

Drug: Capecitabine

Drug: Placebo