Clinical Trial Details

NCT ID: NCT02551991
Date Last Changed: September 29, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Pancreatic Cancer, Metastatic

Research Study Title

A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Purpose

This is an open-label, phase 2 comparative study to assess the safety, tolerability, and efficacy of nal-IRI in combination with other anticancer therapies, compared to nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have not received prior chemotherapy. This study will assess the following regimens:

  • nal-IRI + 5-FU/LV + oxaliplatin

  • nal-IRI + 5-FU/LV

  • nab-paclitaxel + gemcitabine

The study will be conducted in two parts:

  1. a safety run-in of the nal-IRI + 5-FU/LV + oxaliplatin regimen, and

  2. a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI + 5-FU/LV, versus nab-paclitaxel + gemcitabine.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Ipsen
Duration
37 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the pancreas not previously treated in the metastatic setting

Part 1: Unresectable, locally advanced or metastatic disease; diagnosed within 6 wks prior to enrollment; Part 2: Metastatic disease; diagnosed within 6 wks prior to randomization

  • Measurable or non-measurable disease as defined by RECIST v1.1

  • ECOG performance of 0 or 1

  • Adequate hematological, hepatic, renal and cardiac function

Exclusion Criteria:

  • Prior treatment of pancreatic cancer in the metastatic setting with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy

  • Prior treatment of pancreatic cancer with chemotherapy (radiation sensitizer allowed if ≥ 6 months has elapsed from completion)

  • Uncontrolled CNS metastases

  • Clinically significant gastrointestinal disorder

  • History of any second malignancy in the last 3 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible

  • Presence of any contraindications for nal-IRI, irinotecan, 5-FU, leucovorin, oxaliplatin, nab-paclitaxel (part 2 only) or gemcitabine (part 2 only)

  • Use of strong CYP3A4 or CYP2C8 inhibitors or inducers (part 2 only)

  • Pregnant or breast feeding

Site Locations (7)

Country State City Zip Facility and Contact
United States Arizona Glendale 85306 Arizona Center for Cancer Care
United States Arizona Scottsdale 85259 Mayo Clinic Cancer Center
United States California Santa Monica 90404 University of California, Los Angeles (UCLA) Medical Center - Santa Monica Cancer Center
United States Colorado Aurora 80045 University of Colorado (CU) - Anschutz Cancer Pavilion
United States Florida Jacksonville 32224 Mayo Clinic Cancer Center - Jacksonville
United States New York Buffalo 14263 Roswell Park Cancer Institute
Australia Western Australia Subiaco Research Site

Contact

Ipsen Recruitment Enquiries

E-mail:

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