A Study to Evaluate Long-term Safety in Subjects With Solid Tumors and Hematological Disorders.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 125
Summary
- Conditions
- Hematologic Neoplasm
- Neoplasms
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The open-label, multicenter, multinational rollover study is intended to evaluate the safety of CC-486, while providing continued treatment with CC-486 for subjects who are receiving single agent CC-486 at the time of transition to the rollover study and tolerated the protocol prescribed regimen in ...
The open-label, multicenter, multinational rollover study is intended to evaluate the safety of CC-486, while providing continued treatment with CC-486 for subjects who are receiving single agent CC-486 at the time of transition to the rollover study and tolerated the protocol prescribed regimen in Celgene-sponsored trials, and whom in the opinion of the Investigator may derive clinical benefit from continuing treatment with CC-486. Subjects' survival will also be followed if required by the parent CC-486 study protocol. If approved by Celgene, subjects from any ongoing or future Celgene sponsored CC-486 studies in solid tumors and hematological disorders will be included in this protocol.
Tracking Information
- NCT #
- NCT02494258
- Collaborators
- Not Provided
- Investigators
- Study Director: Barry Skikne, MD, FACP; FCP Celgene