NCT00848718

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

A Phase I Dose Escalation Study of MK-2206 in Combination With Standard Doses of Selected Chemotherapies or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-03-17
• Primary completion: 2011-05-19
• Completion: 2012-05-17
• First posted: 2009-02-20
• Last updated: 2019-11-12
• Results posted: 2019-11-12

Regulatory

• FDA-regulated drug study