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
- Colorectal Cancer
- Non-small Cell Lung Cancer
- Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- MM-151 — DRUGMM-151
- MM-121 — DRUGMM-121
- MM-141 — DRUGMM-141
- trametinib — DRUGtrametininb
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
- 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 EscalationMM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers
- Experimental: MM-151+ trametinib Dose EscalationMM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
- Experimental: MM-151+MM-141 Dose EscalationMM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers
- Experimental: MM-151+trametinib Dose EscalationMM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
- Experimental: Colorectal cancer ExpansionDoses established in part 1 of the study
- Experimental: Head and neck ExpansionDoses 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | - |
| Northside Hospital | Sandy Springs | Georgia | 30342 | - |
| Northwestern | Chicago | Illinois | 60611 | - |
| Washington University | St Louis | Missouri | 63110 | - |
| Vanderbilt | Nashville | Tennessee | 37235 | - |
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