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

NCT01110603 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-05-05

No results posted yet for this study

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.

Conditions

  • Cancer: Solid Tumors

Interventions

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

Sponsors & Collaborators

  • Tesaro, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110603 on ClinicalTrials.gov