Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2021-06-28
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen; Merrimack Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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