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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01226901
• Collaborator: (none)
• Enrollment: 3
• Arm: 1
• Duration (Months): 12

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01226901
• Other Study ID Numbers: MK-4827-005
• First Posted: Oct 22, 2010
• Last Update Posted: Jun 28, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by , ,: Poly (ADP-ribose) polymerase (PARP) inhibitor; tumor; cancer
• Additional relevant MeSH terms: Neoplasms; Niraparib

Study Results

No Results Posted as of Jun 28, 2012