Unresectable Advanced Cancer Clinical Trial
Official title:
A Phase Ib Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer - DOUBLIRI
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.
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
;