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FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma

NCT01383538 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-08-08

No results posted yet for this study

Summary

The purpose of this phase I study to determine the optimal dose for the combination of IPI-926 plus FOLFIRINOX (5-fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) chemotherapy in patients with pancreatic cancer.

Conditions

Interventions

DRUG

FOLFIRINOX, IPI-926

Oxaliplatin: intravenous, 50 to 85 mg/m2, over 2 hrs, once per cycle. Leucovorin: intravenous, 400 mg/m2, over 2 hrs, once per cycle. Irinotecan: intravenous, 120 to 180 mg/m2, over 90 minutes, once per cycle. 5-FU: intravenous, 1600 to 2400mg/m2, over 46hr continuous infusion, once per cycle. IPI-926: oral, 130 to 160 mg/day, daily, 14 days per cycle.

Sponsors & Collaborators

  • Infinity Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Andrew Ko

    lead OTHER

Principal Investigators

  • Andrew Ko, M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-23
Primary Completion
2012-12-13
Completion
2015-05-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383538 on ClinicalTrials.gov