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
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's enrollment of 35 is below the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Constellation Pharmaceuticals is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jul 2021 to primary completion in Mar 2023, 19 months.
Of 95 industry-sponsored phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 78. This study's 19 months is below that.
Counting every sponsor, half of 159 studies reached it within 51 months; a quarter within 28 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: CPI-0610
Constellation Pharmaceuticals