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

Phase 1TerminatedNCT01110603

Tesaro, Inc.12 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer: Solid Tumors

Interventions

MK-4827DRUG

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.

carboplatinDRUG

Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle

paclitaxelDRUG

Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of participants with dose limiting toxicities (DLTs)

Time frame: Each cycle (21 or 28 Days)

Secondary Outcomes

Number of participants with clinical and laboratory adverse events (AEs)

Time frame: Baseline to 30 days post last dose

Data from ClinicalTrials.gov

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