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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226901
Recruitment Status : Terminated
First Posted : October 22, 2010
Last Update Posted : June 28, 2012
Information provided by:
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Neoplasms Solid Tumors Drug: MK-4827 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of MK-4827 in Patients With Solid Tumor
Study Start Date : November 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp Identifier: NCT01226901     History of Changes
Other Study ID Numbers: MK-4827-005
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Merck Sharp & Dohme Corp.:
Poly (ADP-ribose) polymerase (PARP) inhibitor

Additional relevant MeSH terms:
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents