A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
This trial is active, not recruiting.
|Condition||advanced gastrointestinal tumors|
|Treatments||tas-102, cpt-11, bevacizumab|
|Sponsor||Taiho Oncology, Inc.|
|Start date||September 2013|
|End date||September 2016|
|Trial size||65 participants|
|Trial identifier||NCT01916447, TPU-TAS-102-109|
The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.
|United States||California, Connecticut, Illinois, and New York|
|Other Countries||No locations recruiting|
|Los Angeles, CA||UCLA / Jonsson Comprehensive Cancer Center||recruiting|
|New Haven, CT||Yale University||recruiting|
|Chicago, IL||Northwestern University||recruiting|
|New York, NY||Memorial Sloan-Kettering Cancer Center||recruiting|
|Cleveland, OH||Case Comprehensive Cancer Center||suspended|
|Nashville, TN||Vanderbilt Ingram Cancer Center||no longer recruiting|
|Nashville, TN||Vanderbilt University / Ingram Cancer Center||suspended|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Determine maximum tolerated dose
time frame: Through Cycle 1 and Cycle 2 (ie, 4 weeks)
Safety monitoring including adverse events, vital signs, and laboratory assessments
time frame: Safety is assessed through 30 days following last administration of study medication or until initiation of new anticancer treatment.
Investigate the safety of TAS-102 and CPT-11 at the MTD administered in combination with Bevacizumab (5 mg/kg IV).
time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Investigate the clinical pharmacokinetics (PK) of TAS-102, CPT-11, and their metabolites.
time frame: Blood samples will be collected in Cycle 1 at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 24 and 48 hours post AM dose of TAS-102 in combination with CPT-11.
Document any preliminary antitumor activity of TAS-102 administered in combination with CPT-11 and in combination with CPT-11 and Bevacizumab.
time frame: After every 4 cycles (i.e., every 8 weeks)
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Has provided written informed consent 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: 1. Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 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
|Official title||A Phase 1, Open-label, Non-randomized, Dose-escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-102 in Combination With CPT-11 and Bevacizumab in Patients With Advanced Gastrointestinal Tumors|
|Principal investigator||Leonard Saltz, MD|
|Description||This is an open-label, non-randomized, dose-escalation, Phase 1 study of TAS-102 administered in combination with CPT-11. The study will be conducted in 2 parts: a Dose Escalation Phase (Part 1) to determine the maximum tolerated dose and an Expansion Phase (Part 2) to further evaluate the safety, pharmacokinetics, and preliminary efficacy of the maximum tolerated dose. Patients will be assigned to sequential dose-level cohorts with each cohort corresponding to a pre-specified dose of TAS-102 and CPT-11 combination. Escalation to the subsequent dose level will occur only after the previous dose level is determined to be safe.|
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