Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Phase 1

Completed

• Conditions: Advanced Malignancies; Solid Tumor; Hematological Malignancy
• Interventions: Drug: Pelabresib

• Registration Number: NCT05391022
• Lead Sponsor: Constellation Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Primary Completion: 2023-03-08
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Continuous Treatment Period	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).
Run-In Food Effect Period	Pelabresib	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.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib	24 hours	Ae(∞) and fe of pelabresib excreted into urine

Trial Locations

Locations (10)

Simon Khechinashvili University Hospital; 🇬🇪 Tbilisi, Georgia

K. Eristavi National Center of Experimental and Clinical Surgery; 🇬🇪 Tbilisi, Georgia

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hight Technology Hospital Medcenter; 🇬🇪 Batumi, Georgia

Madrid - FJD; 🇪🇸 Madrid, Spain

START CIOCC Hospital HM Sanchinarro; 🇪🇸 Madrid, Spain

Gettysburg Cancer Center; 🇺🇸 Gettysburg, Pennsylvania, United States

Start Mountain Region; 🇺🇸 West Valley City, Utah, United States

Gabrail Cancer Center Research; 🇺🇸 Canton, Ohio, United States

Barcelona HM Nou Delfos; 🇪🇸 Barcelona, Spain