At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pelabresib (drug)
- How long the study runs
- Study runs about 34 months (dates as stated)
- About the drug or intervention
- Pelabresib — drug: Small molecule inhibitor of bromodomain and extraterminal (BET) protein
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is for people who were already taking a cancer drug called pelabresib in an earlier study. It lets them keep taking the drug if it seems to be helping them, or continue to be checked on for survival after the earlier study. It covers blood cancers, solid tumours and advanced cancers.
Who can take part
- You must be at least 18 years old and able to give consent.
- You were already in an earlier pelabresib study.
- For ongoing treatment: you are currently taking pelabresib and it seems to be helping you, as judged by the study doctor.
- You are willing and able to attend all study visits and follow the study rules.
- If you can have children, you or your partner must use very effective contraception (at least 99% effective). Men must avoid donating sperm for 94 days after treatment; women must avoid pregnancy, breastfeeding and egg donation for 184 days after treatment.
- For survival follow-up only: you were in an earlier pelabresib study and agree to follow-up checks.
Who may not be able to
- You are legally institutionalised or under judicial protection.
- You are taking part in another treatment study (apart from the earlier pelabresib study).
- You have had a bad allergic reaction to pelabresib or similar drugs.
- You have serious gut problems, such as inflammatory bowel disease or ongoing sickness, vomiting or diarrhoea, that could affect how the drug is absorbed.
- You have another medical condition that the study doctor thinks makes the study unsuitable or unsafe for you.
- You had other cancer treatment or an experimental drug within 2 weeks or 5 half-lives before the first dose (hydroxyurea or anagrelide are allowed up to 24 hours before).
- You had growth factors for blood cells or androgenic steroids within 4 weeks before the first dose.
- You have taken strong medicines or herbal products that affect how pelabresib is processed (CYP3A4 inhibitors or inducers, for example St John's wort) within 2 weeks before the first dose — these are not allowed during the study either.
- You are pregnant, breastfeeding, or not willing to use contraception as required.
What taking part involves
- • Taking pelabresib, the same drug you were given in your earlier study.
- • Attending study visits and following the study procedures.
- • Some people may take part in survival follow-up only, which means checks after the earlier study without further treatment.
- • Contraception rules apply during treatment and for a set time afterwards.
Time commitment: Not stated — ask the trial team (the data does not say how often visits happen or how long the study lasts).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 50
- Started
- 2024-08-13
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for hematologic malignancy
- • Phase3 - 50 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hematologic malignancy
Where?
- • Cardiff - Novartis Investigative Site
- • Glasgow - Novartis Investigative Site
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
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 will be assessed by the investigator and treatment with pelabresib can be started at the same dose and dosing schedule that was applied in the parent study in the last cycle prior to EOT unless there is need for dose adjustment due to toxicity. A patient is considered to have completed the study after completion of all visits as defined in the Schedule of Assessments (SoA) as per protocol, including the Safety Follow-up visit and Survival Follow-up. The Safety Follow-up period is the interval between the EOT visit and the scheduled Safety Follow-up visit, which should occur 30 days (±3 days) after the last dose of pelabresib. For patients who switch from investigational pelabresib to commercial pelabresib treatment, the Safety Follow-up period is the time from the last dose of investigational pelabresib until the first dose of commercial pelabresib. The treatment start date with commercial pelabresib will be considered the date of "early Safety Follow-up termination." All patients will be followed for AEs and SAEs for 30 days (±3 days) following the last dose of pelabresib on the extension study or until the initiation of a new anticancer therapy, whichever occurs first. Reasonable efforts should be made to have the patient return for the Safety Follow-up visit and review any AEs that may occur during this period. If the patient cannot return to the site for the Safety Follow-up visit, then the patient should be contacted by telephone for assessment of AEs. The end of study will occur when all parent studies have been closed with no further patients expected to be enrolled into the extension study, and the last patient in the extension study has permanently discontinued study treatment (investigational pelabresib) and has completed the Safety Follow-up visit or is designated as lost to follow-up, died, or has withdrawn consent, whichever comes first. The sponsor reserves the right to close a study site or terminate the study at any time for any reason at the sole discretion of the sponsor.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Eligibility for Ongoing Pelabresib Treatment
- ✓Able to provide signed agreement to take part, 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.
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (3 UK sites)
Novartis Investigative Site
Cardiff CF14 4XW, United Kingdom
Novartis Investigative Site
Glasgow G12 0YN, United Kingdom
Novartis Investigative Site
London SE1 7EH, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT