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 (Madison)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02436135|
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : December 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis||Drug: Idelalisib Drug: Ruxolitinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Idelalisib in Subjects Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease|
|Actual Study Start Date :||June 5, 2015|
|Actual Primary Completion Date :||November 20, 2017|
|Actual Study Completion Date :||November 20, 2017|
Experimental: Idelalisib Dose Escalation
Four successive cohorts of participants will each be started on a fixed dose of idelalisib. Based on safety data after the third participant completes Day 28, the cohort may be expanded to enroll an additional 3 participants. After the sixth participant completes Day 56, the next cohort will be open to enrollment after safety and PK data at this dose have been evaluated. For the successive 3 cohorts, enrollment will be expanded based on cumulative safety and PK data. Participants will continue ruxolitinib dosing during screening and throughout the study treatment period.
Idelalisib tablets administered orally for 24 weeks
Ruxolitinib will be administered per standard of care according to package insert
- Adverse events (AEs), abnormal laboratory tests, and drug discontinuations due to AEs and serious AEs [ Time Frame: Up to 28 days ]This endpoint will measure the safety profile of idelalisib and ruxolitinib after 28 days of exposure.
- Plasma pharmacokinetics (PK) profiles of ruxolitinib (and metabolite[s], as applicable) and idelalisib and/or its primary metabolite, GS-563117: Cmax, Tmax, AUC, and Ctrough [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 10; predose and 1.5 hour postdose on Days 15, 36, 78 and 162 ]This endpoint will measure the plasma PK profiles of ruxolitinib (and metabolite[s], as applicable) and idelalisib and/or its primary metabolite, GS-563117. PK parameters that will be measured include Cmax, Tmax, AUC, and Ctrough.
- AEs, abnormal laboratory tests, and drug discontinuations due to AEs and serious AEs [ Time Frame: Up to 24 weeks plus 30 days ]This endpoint will measure the safety profile of idelalisib and ruxolitinib beyond 28 days of exposure.
- Rate of overall response [ Time Frame: Up to 24 weeks ]Overall response will be measured by complete response, partial response, or clinical improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436135
|United States, California|
|Stanford Hospital and Clinics|
|Stanford, California, United States, 94305|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Study Director:||Gilead Study Director||Gilead Sciences|