Pelabresib for Cancer

Recruiting at 15 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Constellation Pharmaceuticals

Must be taking: Pelabresib

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled illness, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is: 1. To provide continued pelabresib treatment to patients who have previously received pelabresib in a parent study and continue collecting safety and efficacy information 2. To evaluate the overall survival and leukemia-free survival of patients who discontinued placebo or pelabresib treatment in pelabresib parent studies

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Eligibility Criteria

This trial is for adult patients who have solid or blood cancers and were previously treated with Pelabresib in an earlier study. They must be benefiting from the treatment, able to follow the study plan, and give informed consent. Only those still receiving benefits from Pelabresib will continue treatment; others can participate in survival data collection.

Inclusion Criteria

Eligibility for Ongoing Pelabresib Treatment: Receiving clinical benefit from treatment with pelabresib in the parent study

I am willing and able to follow the study's treatment and visit schedule.

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival): Patient has been enrolled in a clinical study with pelabresib

Exclusion Criteria

Eligibility for Ongoing Pelabresib Treatment: Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival): Patients who are legally institutionalized or under judicial protection

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Extension Treatment

Continued pelabresib treatment for patients who previously received pelabresib in a parent study

5 years

Regular visits as per study protocol

Survival Follow-up

Collection of survival data, including overall survival and leukemia-free survival, for patients who continued or discontinued treatment

5 years

Data collection visits

Treatment Details

Interventions

• Pelabresib (BET Bromodomain Inhibitor)

Trial Overview The trial provides ongoing access to Pelabresib for eligible patients from a previous study. It aims to gather more information on safety, effectiveness, leukemia-free survival, and overall lifespan after treatment ends.

Participant Groups

Group I: Pelabresib Experimental Treatment 1 Intervention

This is a multicenter, open-label extension study for patients previously enrolled in studies with pelabresib. The study does not define separate treatment arms. The study provides continued pelabresib treatment for patients who previously received pelabresib in a parent study. Patients previously enrolled in studies with pelabresib who discontinued treatment with placebo or pelabresib may be enrolled in this extension study for the purpose of survival follow-up.

Who Is Running the Clinical Trial?

Constellation Pharmaceuticals

Lead Sponsor

Trials

10

Recruited

1,500+