drugset / Trial / NCT01702285

Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Cancer Patients

NCT01702285 ↗

Phase 1 Terminated 3 enrolled Curis, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine the safety and tolerability of orally administered CUDC-101 in cancer patients, and to determine a dose for further testing. This study will also determine how well CUDC-101 is absorbed into the blood after being given orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has been administered to cancer patients as an intravenous (IV) infusion in other research studies, but has not been studied when given orally.

Timeline

Start
2012-09
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CUDC-101 Small molecule 200 mg Oral
Subject CUDC-101 Small molecule 500 mg Oral

Indications