NCT02281084

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group to Evaluate the Efficacy and Safety of Cc-486 (Oral Azacitidine) Alone in Combination With Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Oral Azacitidine	Oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
DRUG	Durvalumab	Durvalumab 1500 mg by IV infusion on Day 1 of each 28 day treatment cycle.

Timeline

• Start date: 2015-07-06
• Primary completion: 2019-06-19
• Completion: 2023-09-14
• First posted: 2014-11-03
• Last updated: 2024-10-04
• Results posted: 2020-07-08

Locations

89 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Poland, Spain, United Kingdom