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

May 4, 2016 updated by: Tesaro, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-4827 + carboplatin
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
Experimental: MK-4827 + carboplatin/paclitaxel
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
Experimental: MK-4827 + carboplatin/liposomal doxorubicin
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: liposomal doxorubicin
Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with dose limiting toxicities (DLTs)
Time Frame: Each cycle (21 or 28 Days)
Each cycle (21 or 28 Days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with clinical and laboratory adverse events (AEs)
Time Frame: Baseline to 30 days post last dose
Baseline to 30 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tesaro, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (Estimate)

April 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010_528
  • MK-4827-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer: Solid Tumors

Clinical Trials on MK-4827

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe