Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT01192165
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Trametinib (GSK1120212) — DRUG
    Investigational small molecule targeted therapy (MEK1/2 inhibitor)
  • Docetaxel — DRUG
    Chemotherapy
  • Erlotinib — DRUG
    Small molecule targeted therapy (EGFR inhibitor)
  • Pemetrexed — DRUG
    Chemotherapy
  • Carboplatin — DRUG
    Chemotherapy
  • nab-Paclitaxel — DRUG
    Chemotherapy
  • Cisplatin — DRUG
    Chemotherapy

Study Details

The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.

Key Dates

Start date
Sep 14, 2010
Status verified
Nov 2017
Primary completion
Oct 7, 2013
Completion
Oct 7, 2013

Study Design

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

Arms

  • Experimental: Treatment Group 1
    Trametinib plus Docetaxel
  • Experimental: Treatment Group 2
    Trametinib plus Erlotinib
  • Experimental: Treatment Group 3
    Trametinib plus Pemetrexed
  • Experimental: Treatment Group 4
    Trametinib plus Pemetrexed and Carboplatin
  • Experimental: Treatment Group 5
    Trametinib plus nab-Paclitaxel
  • Experimental: Treatment Group 6
    Trametinib plus Pemetrexed and Cisplatin

Primary Outcome Measure

To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination [ Time Frame: Duration of study (approximately 3 years) ]

Locations (13)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteScottsdaleArizona85259-
GSK Investigational SiteDuarteCalifornia91010-
GSK Investigational SiteSacramentoCalifornia95817-
GSK Investigational SiteDenverColorado80218-
GSK Investigational SiteLas VegasNevada89169-
GSK Investigational SiteAlbanyNew York12206-
GSK Investigational SiteGreenvilleSouth Carolina29605-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteDallasTexas75246-
GSK Investigational SiteHoustonTexas77030-
GSK Investigational SiteTylerTexas75702-
GSK Investigational SiteNorfolkVirginia23502-
GSK Investigational SiteVancouverWashington98684-

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GSK Investigational Site· Scottsdale, AZGSK Investigational Site· Duarte, CAGSK Investigational Site· Sacramento, CAGSK Investigational Site· Denver, COGSK Investigational Site· Las Vegas, NVGSK Investigational Site· Albany, NY

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