Overview

This trial is active, not recruiting.

Condition advanced gastrointestinal tumors
Treatments tas-102, cpt-11, bevacizumab
Phase phase 1
Sponsor Taiho Oncology, Inc.
Start date September 2013
End date September 2016
Trial size 65 participants
Trial identifier NCT01916447, TPU-TAS-102-109

Summary

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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 camptothecin-11, irinotecan
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 Avastin
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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)

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Taiho Oncology, Inc..