ClinicaliQ Trial Snapshot
- An Extension Study for Patients Previously Enrolled in Studies With Pelabresib — Recruiting • Phase III • Oncology • NCT06401356.
- What is being tested: Long-term safety and clinical benefit of pelabresib (a BET inhibitor) in patients with hematological and/or solid tumors, including evaluation of those who previously received placebo in earlier trials and may now receive active drug.
- Patient eligibility overview: The study enrolls patients with prior pelabresib trial participation, including those from placebo-controlled arms seeking access to active treatment, alongside patients with advanced hematological or solid malignancies meeting specified safety and performance criteria.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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. * 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. 2. 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.