Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Merrimack Pharmaceuticals
Study ID
NCT02538627
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MM-151 — DRUG
    MM-151
  • MM-121 — DRUG
    MM-121
  • MM-141 — DRUG
    MM-141
  • trametinib — DRUG
    trametininb

Study Details

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

Key Dates

First listed
Sep 2, 2015
Start date
Aug 31, 2015
Status verified
Aug 2017
Primary completion
Oct 5, 2016
Completion
Oct 5, 2016

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MM-151+MM-121 Dose Escalation
    MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers
  • Experimental: MM-151+ trametinib Dose Escalation
    MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
  • Experimental: MM-151+MM-141 Dose Escalation
    MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers
  • Experimental: MM-151+trametinib Dose Escalation
    MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
  • Experimental: Colorectal cancer Expansion
    Doses established in part 1 of the study
  • Experimental: Head and neck Expansion
    Doses established in part 1 of the study

Primary Outcome Measure

To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers [ Time Frame: 1.5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-
Northside HospitalSandy SpringsGeorgia30342-
NorthwesternChicagoIllinois60611-
Washington UniversitySt LouisMissouri63110-
VanderbiltNashvilleTennessee37235-

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