Clinical Trials Directory

Trials / Terminated

TerminatedNCT02698176

A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Advanced Solid Tumors (MK-8628-006)

A Phase IB Dose Exploration Trial With MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Advanced Solid Tumors

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a study to determine the recommended dose of birabresib (MK-8628)(formerly known as OTX015) for further studies in participants with advanced nuclear protein in testis (NUT) midline carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or castration-resistant prostate cancer (CRPC). This is a two-part parallel study: Part A will establish the recommended dose by evaluating dose limiting toxicity (DLT), safety, discontinuation, and early efficacy and Part B will enroll participants with NMC only and will evaluate safety and efficacy in this population.

Detailed description

The sponsor decided to terminate the program after evaluation of safety and efficacy data at the dose levels tested (Part A). The decision to discontinue the birabresib program was based on limited efficacy signals and was not due to safety-related concerns. No participants entered or were treated in Part B of the study.

Conditions

Interventions

TypeNameDescription
DRUGBirabresibAdministered as an oral capsule in a fasted state

Timeline

Start date
2016-05-04
Primary completion
2017-04-26
Completion
2017-04-26
First posted
2016-03-03
Last updated
2021-01-27
Results posted
2018-11-05

Regulatory

Source: ClinicalTrials.gov record NCT02698176. Inclusion in this directory is not an endorsement.