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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000896-38 | EudraCT Number | ||
| CDAK539A12106 | Other Identifier | Novartis |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Run-In Food Effect Period | Experimental | 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. |
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| Continuous Treatment Period | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelabresib | Drug | Pelabresib monohydrate tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| -In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib | Ae(∞) and fe of pelabresib excreted into urine | 24 hours |
| Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States | ||
| Gettysburg Cancer Center |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Safety: TEAEs and treatment-emergent SAEs |
| 12 months |
| Gettysburg |
| Pennsylvania |
| 17325 |
| United States |
| Start Mountain Region | West Valley City | Utah | 84119 | United States |
| Hight Technology Hospital Medcenter | Batumi | Georgia |
| K. Eristavi National Center of Experimental and Clinical Surgery | Tbilisi | Georgia |
| Simon Khechinashvili University Hospital | Tbilisi | Georgia |
| Barcelona HM Nou Delfos | Barcelona | 08023 | Spain |
| Madrid - FJD | Madrid | 28040 | Spain |
| START CIOCC Hospital HM Sanchinarro | Madrid | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |