NCT02640365

A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer

A Phase Ib Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer - DOUBLIRI

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal formulation is designed to extend plasma circulation and to increase accumulation in the tumor through the enhanced permeability and retention (EPR) effect. This study introduces a new concept of combining free and nanoliposomal drugs.

Detailed description

This is a dose-finding and therapeutic exploratory phase Ib multi-center, open label study of MM-398 plus irinotecan in two different settings: * Group A : patients with unresectable advanced non-colorectal cancer who should receive only MM-398 and irinotecan * Group B : patients with unresectable metastatic colorectal cancer who should receive MM-398 and irinotecan combined with leucovorin, 5-fluorouracil and bevacizumab. These groups will be enrolling in parallel. Pharmacokinetic and biomarker sampling will also be performed. There are three periods to this study : Screening period (up to -28d): patients undergo screening assessments to determine the eligibility for the study MM-398 treatment period (C1D1 until safety evaluation/progression): patients receive treatment every 2 weeks and undergo biopsies and other required assessments. The treatment period is divided into a maximum of 3 dose levels Follow up period: patients will be followed-up 30 days after their last dose of MM-398 for final safety assessments, and every 2 months thereafter for overall survival follow-up

Conditions

• Unresectable Advanced Cancer

Interventions

Type	Name	Description
DRUG	MM-398	unresectable Advanced non-colorectal cancer
DRUG	Irinotecan	unresectable metastatic colorectal cancer
DRUG	Leucovorin (LV)	unresectable metastatic colorectal cancer
DRUG	5-fluorouracile (5-FU)	unresectable metastatic colorectal cancer
DRUG	bevacizumab	unresectable metastatic colorectal cancer
DRUG	MM-398	unresectable metastatic colorectal cancer

Timeline

• Start date: 2015-11-18
• Primary completion: 2016-12-07
• Completion: 2016-12-07
• First posted: 2015-12-28
• Last updated: 2017-01-31

Locations

1 site across 1 country: France