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

NCT02640365 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-01-31

No results posted yet for this study

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.

Conditions

  • Unresectable Advanced Cancer

Interventions

DRUG

Leucovorin (LV)

unresectable metastatic colorectal cancer

DRUG

5-fluorouracile (5-FU)

unresectable metastatic colorectal cancer

DRUG

MM-398

unresectable Advanced non-colorectal cancer

DRUG

Irinotecan

unresectable metastatic colorectal cancer

DRUG

bevacizumab

unresectable metastatic colorectal cancer

DRUG

MM-398

unresectable metastatic colorectal cancer

Sponsors & Collaborators

  • Merrimack Pharmaceuticals

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Benoist Chibaudel, MD · Franco-British Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-18
Primary Completion
2016-12-07
Completion
2016-12-07

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02640365 on ClinicalTrials.gov