NCT02805660

Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor. This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Mocetinostat - 50 mg	Participants received mocetinostat three times weekly as an oral capsule.
DRUG	Mocetinostat - 70 mg	Participants received mocetinostat three times weekly as an oral capsule.
DRUG	Mocetinostat - 90 mg	Participants received mocetinostat three times weekly as an oral capsule.
DRUG	Mocetinostat - Recommended Phase 2 Dose (70 mg)	Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
DRUG	Durvalumab - 1500 mg	Participants received durvalumab as an intravenous infusion every 4 weeks.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-12-14
• Completion: 2019-12-20
• First posted: 2016-06-20
• Last updated: 2021-04-06
• Results posted: 2021-04-06

Locations

15 sites across 1 country: United States