Pelabresib for Cancer

Recruiting at 15 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Constellation Pharmaceuticals

Must be taking: Pelabresib

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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).

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.

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Pelabresib

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.

How Is the Trial Designed?

Group I: Pelabresib Experimental Treatment 1 Intervention

All eligible participants will receive continued treatment with pelabresib as administered in the relevant parent study. Participants 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+

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD