A Phase 1 interventional study of Pelabresib in Advanced Malignancies, Solid Tumor and Hematological Malignancy, sponsored by Constellation Pharmaceuticals. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Constellation Pharmaceuticals · Phase 1, Interventional, and Treatment
Phase 1 2-part study to evaluate the effect of food on pharmacokinetics of pelabresib (CPI-0610) and the effect of pelabresib on QTc in patients with advanced malignancies
Exclusion Criteria:
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.
Drug: Pelabresib
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).
Drug: Pelabresib
Pelabresib monohydrate tablets
Also known as: CPI 0610
Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay
The primary endpoint for the food effect is to investigate the effects high and low-fat meals have on the oral bioavailability of single doses of pelabresib
Time frame: 21 days
Run-In Food Effect Period: maximal plasma concentration (Cmax) based on pelabresib concentrations in plasma measured using validated plasma assay
The primary endpoint for the food effect is to investigate the effects high and low-fat meals have on the oral bioavailability of single doses of pelabresib
Time frame: 21 days
Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay
The primary endpoint for the food effect is to investigate the effects high and low-fat meals have on the oral bioavailability of single doses of pelabresib
Time frame: 21 days
Continuous Treatment Period: Changes in QT and QTc intervals
The primary endpoint of the QT portion is to determine the effect of single and multiple doses of pelabresib on QT/QTc prolongation
Time frame: 12 months
-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib
Ae(∞) and fe of pelabresib excreted into urine
Time frame: 24 hours
Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Safety: TEAEs and treatment-emergent SAEs
Time frame: 12 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Constellation Pharmaceuticals