Advanced Malignancies, Solid Tumor, Hematological Malignancy
Conditions
Keywords
Pelabresib, CPI 0610
Brief summary
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
Interventions
DRUGPelabresib
Pelabresib monohydrate tablets
Sponsors
Constellation Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay | 21 days | 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 |
| Run-In Food Effect Period: maximal plasma concentration (Cmax) based on pelabresib concentrations in plasma measured using validated plasma assay | 21 days | 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 |
| Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay | 21 days | 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 |
| Continuous Treatment Period: Changes in QT and QTc intervals | 12 months | The primary endpoint of the QT portion is to determine the effect of single and multiple doses of pelabresib on QT/QTc prolongation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| -In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib | 24 hours | Ae(∞) and fe of pelabresib excreted into urine |
| Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) | 12 months | Safety: TEAEs and treatment-emergent SAEs |
Countries
Georgia, Spain, United States
Outcome results
None listed