A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Merrimack Pharmaceuticals
Study ID
NCT00994123
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • MM-121 — DRUG
    MM-121 (SAR256212) = intravenous solution
  • Erlotinib — DRUG
    erlotinib = daily oral tablet

Study Details

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Key Dates

First listed
Oct 14, 2009
Start date
Feb 28, 2010
Status verified
Jul 2016
Primary completion
Nov 30, 2014
Completion
Jun 30, 2015

Study Design

Enrollment
162 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose-Escalation
    Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
  • Active Comparator: Phase 2: Control
    Erlotinib (daily)
  • Experimental: Phase 2: Treatment
    MM-121 (QOW IV) and erlotinib (daily PO)

Primary Outcome Measure

Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC. [ Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35294-
-TucsonArizona85715-
-Loma LindaCalifornia92354-
-SacramentoCalifornia95817-
-San FranciscoCalifornia94115-
-AuroraColorado80045-
-TampaFlorida33612-
-AtlantaGeorgia30322-
-LafayetteIndiana47905-
-BostonMassachusetts02114-
-St LouisMissouri63110-
-BuffaloNew York14263-
-New YorkNew York10065-
-CincinnatiOhio45267-
-PortlandOregon97239-
-PittsburghPennsylvania15232-
-CharlestonSouth Carolina29425-
-NashvilleTennessee37232-
-DallasTexas75390-

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