An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Novartis Pharmaceuticals
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).
Description
The study will collect and monitor ongoing efficacy information with regard to disease and survival status, as well as safety information with regard to AEs, including SAEs and AEs of special interest (AESI). Patients are eligible to continue pelabresib treatment as long as the regimen is tolerated, and the patient does not meet any of the discontinuation criteria. There will be an eligibility check period of up to 28 days for this extension study. Patients who fulfill the inclusion and exclusion criteria are eligible for the study. After the patient willingly provides consent, eligibility w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Eligibility for Ongoing Pelabresib Treatment * Able to provide signed informed consent, agreeing to all protocol and ICF requirements. * At least 18 years old and legally able to consent in the study's jurisdiction. * Previously enrolled and currently receiving pelabresib in a parent study. * Demonstrating clinical benefit from pelabresib, as judged by the investigator. * Willing and able to follow all study visits, treatments, and procedures. * Agree to avoid pregnancy or fathering children: * Men: Must use highly effective contraception (≥99%…
Interventions
- DrugPelabresib
Small molecule inhibitor of bromodomain and extraterminal (BET) protein
Locations (15)
- Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)Los Angeles, California
- Mayo Clinic (Cancer Clinical Research Office)Jacksonville, Florida
- Northwestern Memorial Hospital (Oncology)Chicago, Illinois
- UMHS - University of Michigan Medical Center (Radiation Oncology)Ann Arbor, Michigan
- Mount Sinai Hospital - OncologyNew York, New York
- Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)New York, New York