A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
Eli Lilly and Company
Summary
The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process * Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy * Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit * Have a platelet count less than 30,000/μL on 2 occasions more than 5 days apart in the 15 days before randomization * Have adequate liv…
Interventions
- DrugPirtobrutinib
Administered orally
- DrugPlacebo
Administered orally
Locations (45)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Stanford UniversityStanford, California
- MedStar Georgetown University HospitalWashington D.C., District of Columbia
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer CenterMiami, Florida
- Bleeding and Clotting Disorders InstitutePeoria, Illinois
- Ochsner Clinical FoundationNew Orleans, Louisiana