A Study of MK4827 in Participants With Advanced Solid Tumors or Hematologic Malignancies (MK-4827-001 AM8)
- Conditions
- Solid TumorsChronic Lymphocytic LeukemiaT-cell-prolymphocytic Leukemia
- Interventions
- Registration Number
- NCT00749502
- Lead Sponsor
- Tesaro, Inc.
- Brief Summary
This is a four-part dose-escalation and confirmation study in participants with advanced solid tumors. Part A is for dose escalation and determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of MK-4827. Part B is a prostate/ovarian cancer cohort expansion. Part C is for a cohort of participants with relapsed or refractory T-cell prolymphocytic leukemia (T-PLL) or chronic lymphocytic leukemia (CLL). Part D will be for a cohort of participants with locally advanced or metastatic colorectal carcinoma (CRC), persistent or recurrent endometrial carcinoma, locally advanced or metastatic triple negative or highly proliferative estrogen receptor positive (ER+) breast cancer, or partially platinum-sensitive epithelial ovarian cancer. The study is also designed to find out whether MK-4827 causes at least 50% inhibition of poly adenosine diphosphate ribose polymerase (PARP) enzyme activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part C - T-PLL/CLL cohort MK-4827 - Part D - CRC, endometrial, breast, and ovarian cancer cohort MK-4827 - Part A-Dose escalation and confirmation MK-4827 - Part B - Prostate/Ovarian Cancer Cohort MK-4827 -
- Primary Outcome Measures
Name Time Method Number of participants with dose limiting toxicities (DLTs) Cycle 1 (21 days) Percent inhibition of peripheral blood mononuclear cell PARP enzyme activity (Part A, B, and C) Cycle 1 (Days 1-21)
- Secondary Outcome Measures
Name Time Method