A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
GlaxoSmithKline
Study ID
NCT02065063
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Trametinib — DRUG
    Trametinib is available as a 0.5 mg yellow oval tablet or as a 2.0 mg pink round tablet.
  • Palbociclib — DRUG
    Palbociclib is available as a 75 mg (size 2 sunset yellow) or 100 mg (size 1 sunset yellow/caramel) or 125 mg (size 0 caramel) capsule.

Study Details

This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to determine the recommended dose and schedule for the orally administered MEK inhibitor trametinib, given together with the CDK4/6 inhibitor palbociclib in subjects with solid tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will receive trametinib and/or palbociclib until disease progression, death, consent withdrawal or unacceptable adverse event (AE). Data was only collected and analyzed for the Phase I component of the study, the Phase II component of the study was terminated without data collection

Key Dates

Start date
Apr 22, 2014
Status verified
May 2018
Primary completion
Jun 23, 2016
Completion
Jun 23, 2016

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Part 1 is a dose finding phase in which subjects will be initially administered 75 milligram (mg) of palbociclib (21 days on/7 days off) and 1.5 mg of trametinib (once daily continuous dosing) in each 28-day cycle. Dose escalations will continue based on predefined parameters until the RCR is identified. The RCR will not exceed the maximum tolerated dose (MTD).
  • Experimental: Part 2
    Once the MTD and schedule have been determined, two expansion cohorts of up to 20 subjects each will be enrolled. The cohorts will enroll subjects with BRAF-WT (wild type) cutaneous melanoma that are either NRAS-WT or NRAS-MUT (mutated). Subjects will be dosed at or below the RCR to determine the inhibition of selected tumor biomarkers at each dose level.
  • Experimental: Part 3
    Part 3 will be a randomized Phase II study in which subjects will be administered the RCR as previously identified. Part 3 will be initiated only if an RCR is identified, and sufficient anticancer activity is observed in Parts 1 and 2.

Primary Outcome Measure

Part 1: Change from baseline in vital signs [ Time Frame: Up to 36 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteNashvilleTennessee37232-
GSK Investigational SiteHoustonTexas77030-4009-

Find similar trials in Boston, MA

By research site
GSK Investigational Site· Boston, MAGSK Investigational Site· Nashville, TNGSK Investigational Site· Houston, TX

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