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

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

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

Conditions
-----------------
Neoplasms, Solid Tumors

Intervention / Treatment
-----------------
* Drug: MK-4827


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-4827 once daily<br>MK-4827 | Drug: MK-4827<br>* MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities (DLTs) in Cycle 1 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Poly (ADP-ribose) polymerase (PARP) inhibitor, tumor, cancer