An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
NCT06401356 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-06-22
Summary
The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).
Conditions
- Hematologic Malignancy
- Solid Tumor
- Advanced Malignancies
Interventions
- DRUG
-
Pelabresib
Small molecule inhibitor of bromodomain and extraterminal (BET) protein
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-13
- Primary Completion
- 2027-06-02
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Italy
- Netherlands
- United Kingdom
Study Locations
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