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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tesaro, Inc.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; Liposomal doxorubicin; Niraparib; Paclitaxel

Criteria

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.

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.