An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Novartis Pharmaceuticals
You may qualify if…
- ✓ 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% effective) and avoid sperm donation from eligibility check through 94 days post-treatment.
You may not qualify if…
- ✕ 1. Eligibility for Ongoing Pelabresib Treatment
- ✕ Legally institutionalized or under judicial protection.
- ✕ Enrolled in another interventional clinical trial (excluding the parent study).
- ✕ History of hypersensitivity to pelabresib, its excipients, or similar drugs.
- ✕ Significant gastrointestinal issues (e.g., active IBD, unresolved nausea/vomiting/diarrhea \> Grade 1) that may affect drug absorption.
- ✕ Any medical condition deemed unsuitable by the investigator.
- ✕ Uncontrolled illness or condition that may compromise safety or protocol compliance.
- ✕ Received systemic anticancer or investigational treatment (excluding parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose. (Hydroxyurea/anagrelide allowed up to 24 hours prior.)
Where it's recruiting
Source: ClinicalTrials.gov · NCT06401356 · last updated 2026-06-11