Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Merrimack Pharmaceuticals
Study ID
NCT01520389
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.

Key Dates

Start date
Jan 31, 2012
Status verified
Mar 2018
Primary completion
Dec 31, 2015
Completion
Jan 31, 2016

Study Design

Enrollment
112 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MM-151 Dose Escalation
    MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks
  • Experimental: MM-151 Expansion in KRAS wild type colorectal cancer
    MM-151 given weekly
  • Experimental: MM-151 + irinotecan
    MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks

Primary Outcome Measure

Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies. [ Time Frame: Two years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045-
Horizon Oncology Research, Inc.LafayetteIndiana47905-
Roswell Park Cancer InstituteBuffaloNew York14263-
South Texas Accelerated Research Therapeutics, LLC (START)San AntonioTexas78229-

Find similar trials in Aurora, CO

By condition
Colorectal cancerLung cancerBreast cancer
By specialty
OncologyGI oncologyLung oncologyLung diseaseBreast oncologyWomen's health
By research site
University of Colorado Denver· Aurora, COHorizon Oncology Research, Inc.· Lafayette, INRoswell Park Cancer Institute· Buffalo, NYSouth Texas Accelerated Research Therapeutics, LLC (START)· San Antonio, TX

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