Clinical trial · Interventional
Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies
A 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
NCT05391022CI-TRIAL-00092672completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelabresib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Run-In Food Effect Period
- description
- 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.
- interventionNames
- Drug: Pelabresib
- type
- EXPERIMENTAL
- label
- Continuous Treatment Period
- description
- 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).
- interventionNames
- Drug: Pelabresib
Primary outcomes (4)
- measure
- Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Confirmed diagnosis of an advanced malignancy for which no effective standard treatment options are available * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 Exclusion Criteria: * Chronic or active conditions and/or concomitant medication use that would prohibit treatment
References
Publications (0)
Data not yet available
No reference posted for this study.