Clinical trialPhase 1 / Phase 2Active not recruiting
TAS102 in Combination With NAL-IRI in Advanced GI Cancers
A Phase I/II Study of Trifluridine/Tipiracil (TAS102) in Combination With Nanoliposomal Irinotecan (NAL-IRI) in Advanced GI Cancers
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 30 January 2018
- Expected end
- 28 November 2025
- Enrollment
- 64 participants
- Sites
- 3
- Primary outcomes
- Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan; Overall response rate based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Sponsor
- Other
- Results posted
- No
- Last update
- 7 January 2025
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Brief summary public domain (ClinicalTrials.gov)
This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. Determine the recommended phase II dose for the combination of TAS-102 and nanoliposomal irinotecan (nanoliposomal \[nal\]-IRI). (Phase I) II. Evaluate the activity of the combination of TAS102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. (Phase II) SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of TAS-102 and nal-IRI. II. Evaluate the response duration, progression free, and overall survival of the combination of TAS-102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive nanoliposomal irinotecan intravenously (IV) over 90 minutes on day 1 and trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 8 or 12 weeks thereafter.