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

NCT ID: NCT01226901

Last Updated: 2012-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-11-30

Brief Summary

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

Conditions

Neoplasms; Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-4827 once daily

MK-4827

Group Type: EXPERIMENTAL

MK-4827

Intervention Type: DRUG

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

Interventions

MK-4827

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck Sharp & Dohme Corp

Other Identifiers

MK-4827-005

Identifier Type: -

Identifier Source: org_study_id