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Cancer drug pelabresib gets Long-Term safety check in extension trial

NCT ID NCT06401356

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety and benefits of the drug pelabresib in people with blood cancers, solid tumors, or advanced cancers. It includes up to 50 adults who were in earlier pelabresib studies and are still benefiting from the drug. Some participants who received placebo or stopped pelabresib may also join to track survival over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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% 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 clinical study. * Are willing and able to comply with follow-up procedures. Exclusion Criteria: 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.) * 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. 2. Eligibility for Survival Follow-up • They are legally institutionalized or under judicial protection.

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Conditions

The condition(s) this trial relates to.

cancer hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced malignancies Hematologic malignancy Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mt Sinai Medical Center

    RECRUITING

    New York, New York, 10029-6574, United States

  • New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    RECRUITING

    Antwerp, 2030, Belgium

  • Novartis Investigative Site

    RECRUITING

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    RECRUITING

    Varese, VA, 21100, Italy

  • Novartis Investigative Site

    RECRUITING

    Novara, 28100, Italy

  • Novartis Investigative Site

    RECRUITING

    Amsterdam, 1081, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Uni Of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of California LA

    RECRUITING

    Los Angeles, California, 90095, United States

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