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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
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
- Blood Cancers
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
-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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
9 Previous Clinical Trials
1,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition or are taking medication that would make it impossible for you to receive treatment.You have a type of cancer that has spread and no standard treatments are available to help.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Treatment Period
- Group 2: Run-In Food Effect Period
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.