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Clinical trial

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

ID
Name
CPI 0610-05
Description
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
Trial arms
Trial start
2021-07-20
Estimated PCD
2023-03-08
Trial end
2024-02-29
Status
Completed
Phase
Early phase I
Treatment
Pelabresib
Pelabresib monohydrate tablets
Arms:
Continuous Treatment Period, Run-In Food Effect Period
Other names:
CPI 0610
Size
35
Primary endpoint
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
Run-In Food Effect Period: maximal plasma concentration (Cmax) based on pelabresib concentrations in plasma measured using validated plasma assay
21 days
Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay
21 days
Continuous Treatment Period: Changes in QT and QTc intervals
12 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}
Updated at
2024-03-05

1 organization

1 product

3 indications

Organization
Constellation Pharmaceuticals
Product
Pelabresib
Indication
Advanced Malignancies
Indication
Solid Tumor
Indication
Hematological Malignancy