A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

Part of paid clinical trials in San Francisco, California.

Sponsor
Merrimack Pharmaceuticals
Study ID
NCT01451632
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • MM-121 — DRUG
    escalating doses MM-121 IV QW
  • Irinotecan — DRUG
    180 mg/m2 IV Q2W
  • Cetuximab — DRUG
    escalating doses cetuximab IV QW

Study Details

The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

Key Dates

Start date
Oct 31, 2011
Status verified
Sep 2016
Primary completion
Nov 30, 2013
Completion
Jun 30, 2014

Study Design

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

Arms

  • Experimental: Part 1: MM-121 + cetuximab
    increasing doses of weekly MM-121 + weekly cetuximab
  • Experimental: Part 2: MM-121 + cetuximab + irinotecan
    increasing doses of irinotecan + the Recommended Phase 2 Dose/Maximum Tolerated Dose (RP2D/MTD) of MM121 + cetuximab as determined in Part 1

Primary Outcome Measure

Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination [ Time Frame: From date of first dose to 30 days after termination, the longest 48.1 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
-San FranciscoCalifornia94115-
-BostonMassachusetts02115-
-Chapel HillNorth Carolina27599-
-Salt Lake CityUtah84112-

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