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Trial Title:
Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
NCT ID:
NCT01573468
Condition:
Gastric Carcinoma
Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Tesetaxel
Description:
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
Arm group label:
Capecitabine-tesetaxel
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo orally once on Day 1 of each cycle
Arm group label:
Capecitabine-placebo
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14
of each cycle
Arm group label:
Capecitabine-placebo
Arm group label:
Capecitabine-tesetaxel
Other name:
Xeloda
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jaffer Ajani, MD
Phone:
713-745-3917
Investigator:
Last name:
Jaffer Ajani, MD
Email:
Principal Investigator
Facility:
Name:
Krankenhaus Nordwest
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Salah-Eddin Al-Batran, PD Dr. med
Phone:
+49 (0) 69 7601 4420
Investigator:
Last name:
Salah-Eddin Al-Batran, PD Dr. med
Email:
Principal Investigator
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chia-Jui Yen, MD
Phone:
+886 6 2353535 4620
Investigator:
Last name:
Chia-Jui Yen, MD
Email:
Principal Investigator
Start date:
April 2012
Completion date:
August 2014
Lead sponsor:
Agency:
Genta Incorporated
Agency class:
Industry
Source:
Genta Incorporated
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01573468
