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

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT02640365
Phase
PHASE1
Status
Completed

Conditions

  • Unresectable Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MM-398 — DRUG
    unresectable Advanced non-colorectal cancer
  • Irinotecan — DRUG
    unresectable metastatic colorectal cancer
  • Leucovorin (LV) — DRUG
    unresectable metastatic colorectal cancer
  • 5-fluorouracile (5-FU) — DRUG
    unresectable metastatic colorectal cancer
  • bevacizumab — DRUG
    unresectable metastatic colorectal cancer
  • MM-398 — DRUG
    unresectable metastatic colorectal cancer

Study Details

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.

Key Dates

Start date
Nov 18, 2015
Status verified
Jan 2017
Primary completion
Dec 7, 2016
Completion
Dec 7, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GROUP A / GROUP B (two differents cohorts)
    GROUP A (Patients with unresectable advanced non-colorectal cancer ) - irinotecan + MM-398 dose escalation (3-18 patients) Level 1 : initial DOUBLIRI dose 60/90 (0-3 patients) * MM-398 : 60mg/m² * Irinotecan (CPT-11) : 90mg/m² Level 2: DOUBLIRI dose 80/90 (9 - 18 patients) * MM-398 : 80mg/m² * CPT-11: 90mg/m² Level 3A: DOUBLIRI dose 60/120 (12-18 patients) * MM-398 : 60mg/m² * CPT-11: 120mg/m² Level 3B: DOUBLIRI dose : 80/120 (12-18 patients) * MM-398 : 80mg/m² * CPT-11 : 120 mg/m² GROUP B (Patients with unresectable metastatic colorectal cancer)- LV/5FU-bevacizumab+irinotecan+MM-398 dose Escalation (3-18 patients) same level as group A + LV/5FU - bevacizumab regimen : * Bevacizumab : 5mg/kg(day (d) 1) * Leucovorin (LV) : 400mg/m² (d1) * 5-fluorouracile infusion (5 FU) :2400mg/m² (d1,2)

Primary Outcome Measure

Adverse Event (AE) [ Time Frame: Assessed from study inclusion to 30 days after last dose ]