A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
NCT ID: NCT01916447
Last Updated: 2024-09-05
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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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2013-09-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAS-102 and CPT-11 with or without Bevacizumab
TAS-102
Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
CPT-11
Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Bevacizumab
Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Interventions
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TAS-102
Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
CPT-11
Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Bevacizumab
Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy
3. ECOG performance status of 0 or 1
4. Is able to take medications orally
5. Has adequate organ function (bone marrow, kidney and liver)
6. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion Criteria
2. Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure
3. Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies
4. Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components
5. Is a pregnant or lactating female
6. Has had either partial or total gastrectomy
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Leonard Saltz, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Los Angeles Clinical Site
Los Angeles, California, United States
Chicago Clinical Site
Chicago, Illinois, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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TPU-TAS-102-109
Identifier Type: -
Identifier Source: org_study_id
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