An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Novartis Pharmaceuticals
50 participants
Aug 13, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria16
- 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.
- Women of childbearing potential (WOCBP): Must test negative for pregnancy at eligibility, use highly effective contraception through 184 days post-treatment, undergo regular pregnancy testing, and avoid breastfeeding and oocyte donation during this period.
- Women not of childbearing potential (surgically sterile or postmenopausal ≥12 months without other cause) are eligible.
- Note: Women with amenorrhea due to chemo/radiotherapy are considered WOCBP and must use contraception.
- Eligibility for Survival Follow-up
- Provide signed informed consent, agreeing to all protocol and ICF requirements.
- Are at least 18 years old and legally able to consent.
- Were previously enrolled in a pelabresib clinical study.
- Are willing and able to comply with follow-up procedures.
Exclusion Criteria14
- 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.)
- Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose.
- Used strong CYP3A4 inhibitors/inducers (e.g., St. John's wort) within 2 weeks before first dose. Use during treatment is prohibited.
- Female participants who are pregnant, breastfeeding, or not using required contraception.
- Male participants who do not agree to use contraception or refrain from sperm donation as specified.
- Unwilling or unable to comply with the study protocol.
- Eligibility for Survival Follow-up • They are legally institutionalized or under judicial protection.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Small molecule inhibitor of bromodomain and extraterminal (BET) protein
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06401356