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 (Madison)

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Gilead Sciences

Status and phase

Terminated
Phase 1

Conditions

Myelofibrosis

Treatments

Drug: Ruxolitinib
Drug: Idelalisib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02436135
GS-US-397-1245

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry
  • Individuals with PMF, post-PV MF, or post-ET MF classified as high risk or intermediate risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for PMF or DIPSS Plus, if cytogenetics are available
  • Individuals with PMF, post-PV MF, or post-ET MF who are receiving ruxolitinib and meet 2013 Revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria with progressive and relapsed disease, with modifications for progressive disease complete remission (CR), partial remission (PR), or clinical improvement (CI)
  • European Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Required screening laboratory values as described in the protocol
  • Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP)
  • Able to understand and willing to sign the informed consent form

Key Exclusion Criteria:

  • Individuals on a stable ruxolitinib dose of 5 mg once daily
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver
  • Ongoing drug-induced pneumonitis
  • Ongoing inflammatory bowel disease
  • Ongoing alcohol or drug addiction
  • Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
  • Known hypersensitivity to the study investigational medicinal product (IMP), the metabolites, or formulation excipients
  • Unwilling or unable to take oral medication
  • Unresolved non-hematologic toxicities from prior therapies that are > Common terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of alopecia [Grade 1 or 2 permitted])
  • Pregnant or lactating females
  • Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

10 participants in 4 patient groups

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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