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A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Carcinoma

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Trial Information

A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jaffer Ajani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The University of Texas MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TOG301

NCT ID:

NCT01573468

Start Date:

April 2012

Completion Date:

August 2014

Related Keywords:

  • Gastric Carcinoma
  • Carcinoma
  • Stomach Neoplasms

Name

Location

The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009