Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

This is an open-label, phase 2 comparative study to assess the safety, tolerability, and preliminary efficacy of nal-IRI in combination with other anticancer therapies in patients not previously treated for metastatic pancreatic adenocarcinoma. This study will assess the following regimen: • nal-IRI + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin The study will be conducted in two parts: 1. Part 1a: a safety run-in as initial dose exploration 2. Part 1b: dose expansion of the nal-IRI + 5FU/LV + oxaliplatin regimen

Official 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

Keywords

Pancreatic Cancer MM-398 Metastatic pancreatic cancer First line pancreatic cancer treatment Adenocarcinoma Pancreatic Neoplasms Paclitaxel Gemcitabine Oxaliplatin Irinotecan Fluorouracil Albumin-Bound Paclitaxel nal-IRI 5 fluorouracil Leucovorin nal-IRI + 5-FU/LV + oxaliplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
  • Unresectable, locally advanced or metastatic disease; diagnosed within 6 weeks prior to screening
  • At least one tumor lesion measurable by CT or MRI scan (according to RECIST v1.1)
  • ECOG performance status of 0 or 1 at screening and within 72 hours prior to first dose if first dose occurs more than 72 hours post-screening
  • Adequate hematological, hepatic, renal and cardiac function
  • Recovered from the effects of any prior surgery or radiotherapy
  • Patient has a Karnofsky performance status (KPS) ≥ 70 at Screening, and within 72 hours prior to date of first dose if first dose occurs more than 72 hours after screening (Part 1B only)

You CAN'T join if...

  • Prior treatment of pancreatic cancer in the metastatic setting (or locally advanced setting) with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
  • Prior treatment of pancreatic cancer with chemotherapy in adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities present
  • Uncontrolled Central Nervous System (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
  • Use of strong CYP3A4 or inducers or presence of any other contra indications for irinotecan
  • Pregnant or breast feeding
  • Neuroendocrine or acinar pancreatic carcinoma
  • Serum albumin < 3 g/dL at screening visit and within 72 hours prior to first dose if first dose occurs more than 72 hours post screening
  • Patients with symptoms and signs of clinically unacceptable deterioration of primary disease at time of screening
  • Previous treatment with irinotecan-based, nab-paclitaxel-based or gemcitabine-based resulting in disease progression

Locations

  • University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • University of California, Los Angeles (UCLA) Medical Center - Santa Monica Cancer Center
    Santa Monica California 90404 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ipsen
ID
NCT02551991
Phase
Phase 1/2
Study Type
Interventional
Last Updated