Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
Conditions
Gastric Carcinoma
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: Tesetaxel Type: Drug
Name: Placebo Type: Drug
Name: Capecitabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Jaffer Ajani, MD - 713-745-3917
Krankenhaus Nordwest
Frankfurt, Germany
Status: Recruiting
Contact: Salah-Eddin Al-Batran, PD Dr. med - +49 (0) 69 7601 4420
National Cheng Kung University Hospital
Tainan, Taiwan
Status: Recruiting
Contact: Chia-Jui Yen, MD - +886 6 2353535 4620
Start Date
April 2012
Completion Date
August 2014
Sponsors
Genta Incorporated
Source
Genta Incorporated
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page