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

Phase 1

Terminated

• Conditions: Cancer: Solid Tumors
• Interventions: Drug: MK-4827; Drug: carboplatin; Drug: liposomal doxorubicin; Drug: paclitaxel

• Registration Number: NCT01110603
• Lead Sponsor: Tesaro, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-26
• Study Start: 2010-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-03
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
• Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Read More

Exclusion Criteria

• Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
• Participant has had more than two prior lines of chemotherapy.
• Participant has known central nervous system metastases or a primary central nervous system tumor.
• Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
• Participant is known to be human immunodeficiency virus (HIV) positive.
• Participant has a history of Hepatitis B or C.
• Participant has a symptomatic pleural effusion.
• Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-4827 + carboplatin/liposomal doxorubicin	MK-4827	-
MK-4827 + carboplatin	MK-4827	-
MK-4827 + carboplatin/liposomal doxorubicin	liposomal doxorubicin	-
MK-4827 + carboplatin/paclitaxel	MK-4827	-
MK-4827 + carboplatin/paclitaxel	carboplatin	-
MK-4827 + carboplatin	carboplatin	-
MK-4827 + carboplatin/paclitaxel	paclitaxel	-
MK-4827 + carboplatin/liposomal doxorubicin	carboplatin	-

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities (DLTs)	Each cycle (21 or 28 Days)

Secondary Outcome Measures

Name	Time	Method
Number of participants with clinical and laboratory adverse events (AEs)	Baseline to 30 days post last dose