A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01916447|
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastrointestinal Tumors||Drug: TAS-102 Drug: CPT-11 Drug: Bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
|Experimental: TAS-102 and CPT-11 with or without Bevacizumab||
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.
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.
Other Name: camptothecin-11, irinotecan
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 Name: Avastin
- Determine maximum tolerated dose [ Time Frame: Through Cycle 1 and Cycle 2 (ie, 4 weeks) ]The maximum tolerated dose is defined as the highest dose level at which less than 33% of the evaluable patients treated experience a dose-limiting toxicity during Cycle 1 or Cycle 2 (ie, during the first 4 weeks) of study drug administration.
- 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. ]Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
- 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 ]Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
- 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. ]PK analysis for FTD, FTY, TPI, CPT-11, and SN-38 in plasma and will include Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD and TPI: CL/F, Vd/F will be calculated.
- 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) ]Tumor assessments using Response Evlauation Criteria in Solid Tumors (RECIST)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916447
|United States, California|
|Los Angeles Clinical Site|
|Los Angeles, California, United States, 90095|
|United States, Illinois|
|Chicago Clinical Site|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Tennessee|
|Vanderbilt Ingram Cancer Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Leonard Saltz, MD||Memorial Sloan Kettering Cancer Center|