Neoplasms, Solid Tumors
Conditions
Keywords
Poly (ADP-ribose) polymerase (PARP) inhibitor, tumor, cancer
Brief summary
This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.
Interventions
DRUGMK-4827
MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed