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BET inhibitor

Pelabresib for Cancer

Phase 1
Waitlist Available
Research Sponsored by Constellation Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of an advanced malignancy for which no effective standard treatment options are available
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will look at the effects of food on how the body processes a new cancer drug, and also how the drug affects heart function.

Eligible Conditions
  • Advanced Cancers
  • Solid Tumors
  • Blood Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of cancer that has spread and no standard treatments are available to help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Continuous Treatment Period: Changes in QT and QTc intervals
Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay
Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay
+1 more
Secondary outcome measures
-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib
Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Run-In Food Effect PeriodExperimental Treatment1 Intervention
Unblinded, open label drug will be administered once in a fasted state and twice in a fed state with a minimum of 5 days between each dose prior to entering the continuous treatment phase.
Group II: Continuous Treatment PeriodExperimental Treatment1 Intervention
Unblinded, open label drug will be administered once daily for 14 consecutive days followed by a 7 day break, which is considered 1 cycle of treatment (1 cycle = 21 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelabresib
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Constellation PharmaceuticalsLead Sponsor
8 Previous Clinical Trials
1,382 Total Patients Enrolled

Media Library

Pelabresib (BET inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05391022 — Phase 1
Cancer Research Study Groups: Continuous Treatment Period, Run-In Food Effect Period
Cancer Clinical Trial 2023: Pelabresib Highlights & Side Effects. Trial Name: NCT05391022 — Phase 1
Pelabresib (BET inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05391022 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given their stamp of approval to Pelabresib?

"Our team at Power gave Pelabresib a score of 1 due to the limited amount of clinical data available on its safety and efficacy. This is because this trial is currently in phase 1."

Answered by AI

What is the current enrollment count for this clinical research endeavor?

"According to the specified inclusion criteria, 32 patients must be enrolled in this trial. Potential participants can sign up at Gabrail Cancer Center Research (Canton, Ohio) and Start Mountain Region (West Valley City, Utah)."

Answered by AI

Are there still opportunities to enroll in this research program?

"Affirmative. The latest data from clinicaltrials.gov reveals that this research study, which was initially advertised on July 26th 2021 is actively recruiting participants and is looking for 32 people across 3 centres."

Answered by AI
~10 spots leftby Mar 2025