Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease
Stopped early · Phase 1
Conditions studied: Myelofibrosis
In brief
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease. This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).
Key facts
- Study ID
- NCT02436135
- Run by
- Gilead Sciences
- People needed
- 10
- Starts
- 2015-06-05
- Expected to finish
- 2017-11-20
- Last updated by the study team
- 2020-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford Hospital and Clinics — Stanford, California, United States
- University of Michigan Health System — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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