A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

Titre officiel

A Phase II, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Patients With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

Sommaire:

Il s’agit d’une étude ouverte à groupe unique sur l’utilisation de l’idasanutline en monothérapie chez les participants atteints de polycythémie vraie (PV) qui n’ont pas répondu à l’hydroxyurée (HU) ou qui ne la tolèrent pas.

Description de l'essai

Primary Outcome:

  • Composite Response at Week 32 for Ruxolitinib-Naïve Participants With Splenomegaly at Baseline
  • Hematocrit (Hct) Control Without Phlebotomy at Week 32 for Ruxolitinib-Naïve Participants Without Splenomegaly at Baseline
  • Hct Control Without Phlebotomy at Week 32 for All Ruxolinitib-Naïve Participants (With and Without Splenomegaly)
Secondary Outcome:
  • Response per Modified European Leukemia Net (ELN) Criteria at Week 32 for Ruxolitinib-Naïve Participants and All Participants Irrespective of Prior Ruxolitinib Exposure
  • Duration of Response, Including Percentage of Participants With Durable Response Lasting at Least 12 Weeks
  • Composite Response at Week 32 for Participants With Splenomegaly at Baseline Irrespective of Prior Ruxolitinib Exposure
  • Hct Control Without Phlebotomy at Week 32 for Participants Without Splenomegaly at Baseline Irrespective of Prior Ruxolitinib Exposure
  • Hct Control Without Phlebotomy at Week 32 for All Participants (With and Without Splenomegaly) Irrespective of Prior Ruxolitinib Exposure
  • Hct Control Without Phlebotomy at Week 32 for All Participants (With and Without Splenomegaly) Who Had Prior Ruxolitinib Exposure
  • Percentage of Participants With Abnormal Clinical Laboratory Findings
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Percentage of Participants With Abnormal Electrocardiogram (ECG) Findings, Vital Signs, and Physical Findings
  • Percentage of Participants With Concomitant Medications
  • Maximum Serum Concentration Observed (Cmax)
  • Trough Concentration (Ctrough)
  • Time of Maximum Concentration Observed (tmax)
  • Clearance (CL)
  • Apparent clearance (CL/F)
  • Volume or Apparent Volume of Distribution (Vdss/F)
  • Area under the curve (AUC)
  • Half-life (t1/2)
  • Baseline and Mean Change from Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
  • Baseline and Mean Change from Baseline European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • Baseline and Mean Change from Baseline Patient Global Impression of Change (PGIC)

Voir cet essai sur ClinicalTrials.gov

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