A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)

June 26, 2012 updated by: Merck Sharp & Dohme LLC

A Phase I Study of MK-4827 in Patients With Solid Tumor

This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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 must have a histologically or cytologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens.
  • Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale
  • Participant must have adequate organ function (per prespecified laboratory values).

Exclusion Criteria:

  • Participant has had major surgery, chemotherapy, radiotherapy, hormonal or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, or bevacizumab) prior to entering the study.
  • Participant has known central nervous system metastases or a primary central nervous system tumor.
  • Participant is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study.
  • Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
  • Participant with active Hepatitis B or C.
  • Participant has symptomatic ascites or pleural effusion.
  • Participant has interstitial lung disease as a history or current evidence.
  • Participant has known bleeding tendency or coagulation disorder as a history or current evidence, and/or participant is taking any anti-coagulant and/or antiplatelet therapies.
  • Participant has uncontrolled persistent or active infection (acute infection which requires antibiotic or anti-fungal treatment).
  • Participant has participated in a clinical trial with a known Poly (ADP-ribose) polymerase (PARP) inhibitor.

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 once daily
MK-4827
Drug: MK-4827
MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs) in Cycle 1
Time Frame: Cycle 1 of treatment (1 cycle = 21 days)
Dose-limiting toxicities are defined as all adverse experiences that are clearly not related to disease progression or intercurrent illness. In order to be declared a dose-limiting toxicity, an adverse experience must be related (definitely, probably, or possibly) to study therapy.
Cycle 1 of treatment (1 cycle = 21 days)

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK-4827-005

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.

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