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

NCT00848718 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-11-12

Study results available
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Summary

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.

Conditions

  • Locally Advanced, Metastatic Solid Tumors

Interventions

DRUG

MK-2206

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)

DRUG

docetaxel

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

erlotinib

Administered daily (QD) PO in each 21-day cycle

DRUG

carboplatin

Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle

DRUG

paclitaxel

Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle

DRUG

corticosteroid

Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-17
Primary Completion
2011-05-19
Completion
2012-05-17
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00848718 on ClinicalTrials.gov