An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Solid Tumor Clinical Trial

Official title:

An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401356
• Other study ID #: CNST0610C210
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Constellation Pharmaceuticals
• Contact: Medical Information
• Phone: +1 844 667-1992
• Email: medinfo[@]morphosys.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide continued access to treatment with pelabresib for patients who previously received pelabresib in a parent study and to continue collecting safety and efficacy information. By collecting efficacy information, the study team monitors if pelabresib helps the patient with their disease. Additionally, survival follow-up data will be collected. Survival follow-up collects information on the patient's leukemia-free survival and overall survival status (life span) during and after the treatment is ended. If a patient stopped pelabresib treatment on the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment, but they can enter the study for survival-follow up only.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Eligibility for Ongoing Pelabresib Treatment

1. Capable of giving signed informed consent

2. Receiving clinical benefit from treatment with pelabresib in the parent study

3. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Capable of giving signed informed consent Patient must be at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF

2. Patient has been enrolled in a clinical study with pelabresib

3. Willingness and ability to comply with ongoing follow-up as indicated in this protocol

Exclusion Criteria:

Eligibility for Ongoing Pelabresib Treatment

1. Patients who are legally institutionalized or under judicial protection

2. Any medical condition that, in the investigator's opinion, makes the patient unsuitable for the study

3. Patient is able to access pelabresib outside the study

4. 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

5. Female patients who are pregnant or breastfeeding

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Patients who are legally institutionalized or under judicial protection

Related Conditions & MeSH terms

• Advanced Malignancies
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Solid Tumor

Intervention

Drug:
• Pelabresib
Small molecule inhibitor of bromodomain and extraterminal (BET) protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Constellation Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: TEAEs and Serious TEAEs	Occurrence and severity of treatment-emergent adverse events (TEAEs) and serious TEAEs among patients who are receiving pelabresib	5 years
Primary	Survival	Overall survival and leukemia-free survival	5 years
Primary	Time to event endpoints	Time to event endpoints (eg, duration of response, progression-free survival) in patients who are receiving or received pelabresib	5 years