NCT00749502

A Study of MK4827 in Participants With Advanced Solid Tumors or Hematologic Malignancies (MK-4827-001 AM8)

A Phase I Study of MK-4827 in Patients With Advanced Solid Tumors or Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors
• Chronic Lymphocytic Leukemia
• T-cell-prolymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	MK-4827	MK-4827 in 10 mg and 100 mg capsules given daily in a 21 day dosing cycle (dose escalation to RP2D).

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-09-01
• Completion: 2013-06-01
• First posted: 2008-09-09
• Last updated: 2013-07-25