TAS102 in Combination With NAL-IRI in Advanced GI Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Adenocarcinoma
- Colorectal Adenocarcinoma
- Stage IVB Colorectal Cancer
- Metastatic Pancreatic Adenocarcinoma
- Non-Resectable Cholangiocarcinoma
- Stage III Colorectal Cancer
- Stage III Gastric Cancer
- Stage III Pancreatic Cancer
- Stage IV Colorectal Cancer
- Stage IV Gastric Cancer
- Stage IV Pancreatic Cancer
- Unresectable Digestive System Adenocarcinoma
- Stage IVA Colorectal Cancer
- Unresectable Pancreatic Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 panc...
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.
Tracking Information
- NCT #
- NCT03368963
- Collaborators
- Taiho Oncology, Inc.
- Ipsen
- Investigators
- Principal Investigator: Olatunji B. Alese, MD Emory University