GSK1120212 Rollover Study

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01376310
Phase
PHASE2
Status
Terminated

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • GSK1120212 — DRUG
    up to 2 mg/day
  • Docetaxel + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol.
  • Erlotinib + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol.
  • Pemetrexed + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol
  • Carboplatin + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol
  • Nab-paclitaxel + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol
  • Gemcitabine + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol
  • Everolimus + GSK1120212 — DRUG
    dose as defined in the dose escalation protocol

Study Details

This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.

Key Dates

First listed
Jun 20, 2011
Start date
Nov 2, 2010
Status verified
Feb 2019
Primary completion
Jan 18, 2018
Completion
Jan 18, 2018

Study Design

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

Arms

  • Experimental: Cohort A
    Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study.
  • Experimental: Cohort B
    Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months. ]

Locations (13)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteGoodyearArizona85338-
Novartis Investigative SiteScottsdaleArizona85259-
Novartis Investigative SiteSacramentoCalifornia95817-
Novartis Investigative SiteAuroraColorado80045-
Novartis Investigative SiteNew HavenConnecticut06510-
Novartis Investigative SiteSarasotaFlorida34232-
Novartis Investigative SiteNew YorkNew York10016-
Novartis Investigative SitePhiladelphiaPennsylvania19104-
Novartis Investigative SiteNashvilleTennessee37203-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78229-
Novartis Investigative SiteSalt Lake CityUtah84112-
Novartis Investigative SiteTacomaWashington98405-

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Novartis Investigative Site· Goodyear, AZNovartis Investigative Site· Scottsdale, AZNovartis Investigative Site· Sacramento, CANovartis Investigative Site· Aurora, CONovartis Investigative Site· New Haven, CTNovartis Investigative Site· Sarasota, FL

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