Recruitment

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