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

Phase 1

Terminated

• Conditions: Neoplasms; Solid Tumors
• Interventions: Drug: MK-4827

• Registration Number: NCT01226901
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2010-11
• Primary Completion: 2011-02
• Study Completion: 2011-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-4827 once daily	MK-4827	MK-4827

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities (DLTs) in Cycle 1	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.