A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00848718
Phase
PHASE1
Status
Completed

Conditions

  • Locally Advanced, Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • MK-2206 — DRUG
    MK-2206 given by mouth (PO) on Days 1, 3, 5, and 7 of each 21-day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 PO on Day 1 of each 21-day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg)
  • docetaxel — DRUG
    Administered as an IV infusion on Day 1 of each 21-day cycle
  • erlotinib — DRUG
    Administered daily (QD) PO in each 21-day cycle
  • carboplatin — DRUG
    Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle
  • paclitaxel — DRUG
    Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle
  • corticosteroid — DRUG
    Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle

Study Details

The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors. The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.

Key Dates

First listed
Feb 20, 2009
Start date
Mar 17, 2009
Status verified
Nov 2019
Primary completion
May 19, 2011
Completion
May 17, 2012

Study Design

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

Arms

  • Experimental: MK-2206 + carboplatin + paclitaxel
    MK-2206 combined with carboplatin and paclitaxel
  • Experimental: MK-2206 + docetaxel
    MK-2206 combined with docetaxel plus pretreatment with a corticosteroid
  • Experimental: MK-2206 + erlotinib
    MK-2206 combined with erlotinib

Primary Outcome Measure

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 [ Time Frame: Cycle 1 (Up to 21 days) ]