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

Part of paid clinical trials in Stanford, California.

Sponsor
Gilead Sciences
Study ID
NCT02436135
Phase
PHASE1
Status
Terminated

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Idelalisib — DRUG
    Idelalisib tablets administered orally for 24 weeks
  • Ruxolitinib — DRUG
    Ruxolitinib will be administered per standard of care according to package insert

Study Details

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 Dates

Start date
Jun 5, 2015
Status verified
Aug 2020
Primary completion
Nov 20, 2017
Completion
Nov 20, 2017

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A, Idelalisib + Ruxolitinib
    Idelalisib 50 mg once daily in participants receiving ruxolitinib.
  • Experimental: Cohort B, Idelalisib + Ruxolitinib
    Idelalisib 50 mg twice daily in participants receiving ruxolitinib.
  • Experimental: Cohort C, Idelalisib + Ruxolitinib
    Idelalisib 150 mg once daily in participants receiving ruxolitinib.
  • Experimental: Cohort D, Idelalisib + Ruxolitinib
    Idelalisib 150 mg twice daily in participants receiving ruxolitinib.

Primary Outcome Measure

Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure [ Time Frame: First dose date up to 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford Hospital and ClinicsStanfordCalifornia94305-
University of Michigan Health SystemAnn ArborMichigan48109-

Find similar trials in Stanford, CA

By research site
Stanford Hospital and Clinics· Stanford, CAUniversity of Michigan Health System· Ann Arbor, MI

Related Studies