NCT01110603

A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)

A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.

Detailed description

The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.

Conditions

• Cancer: Solid Tumors

Interventions

Type	Name	Description
DRUG	MK-4827	Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
DRUG	carboplatin	Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
DRUG	paclitaxel	Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
DRUG	liposomal doxorubicin	Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-04-26
• Last updated: 2016-05-05