A Study of MGCD265 Given With Erlotinib or Docetaxel in Subjects With Advanced Malignancies or Non-Small Cell Lung Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT00975767
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Malignancies, Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • MGCD265+erlotinib — DRUG
    MGCD265 and erlotinib administered daily
  • MGCD265+docetaxel — DRUG
    MGCD265 administered daily; docetaxel administered once every 3 weeks

Study Details

The main purpose of this study is to assess the safety profile of MGCD265 when administered in combination with the marketed anticancer drugs erlotinib and docetaxel.

Key Dates

First listed
Sep 11, 2009
Start date
Aug 31, 2009
Status verified
Jan 2015
Primary completion
Jul 31, 2013
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: MGCD265+erlotinib
  • Experimental: MGCD265+docetaxel

Primary Outcome Measure

Phase I: Safety profile (including maximum tolerated dose and dose limiting toxicities) [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer CenterDetroitMichigan48201-
Duke University Medical CenterDurhamNorth Carolina27710-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229-

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