Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
NCT ID: NCT01573468
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
580 participants
INTERVENTIONAL
2012-04-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Capecitabine-tesetaxel
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
Tesetaxel
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
Capecitabine
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
Capecitabine-placebo
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Placebo
Placebo orally once on Day 1 of each cycle
Capecitabine
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
Interventions
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Tesetaxel
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
Placebo
Placebo orally once on Day 1 of each cycle
Capecitabine
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Genta Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jaffer Ajani, MD
Role: STUDY_CHAIR
The University of Texas MD Anderson Cancer Center
Locations
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The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Krankenhaus Nordwest
Frankfurt, , Germany
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Jaffer Ajani, MD
Role: primary
Salah-Eddin Al-Batran, PD Dr. med
Role: primary
Chia-Jui Yen, MD
Role: primary
Other Identifiers
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2010-022164-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TOG301
Identifier Type: -
Identifier Source: org_study_id