Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391022
• Other study ID #: CPI 0610-05
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Constellation Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 29, 2024
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignancies
• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms
• Solid Tumor

Intervention

Drug:
• Pelabresib
Pelabresib monohydrate tablets

Locations

Country	Name	City	State
Georgia	Hight Technology Hospital Medcenter	Batumi
Georgia	K. Eristavi National Center of Experimental and Clinical Surgery	Tbilisi
Georgia	Simon Khechinashvili University Hospital	Tbilisi
Spain	Barcelona HM Nou Delfos	Barcelona
Spain	Madrid - FJD	Madrid
Spain	START CIOCC Hospital HM Sanchinarro	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Start Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Constellation Pharmaceuticals

Countries where clinical trial is conducted

United States,  Georgia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	-In Food Effect Period: Total amount (Ae[8]) and fraction of dose (fe) of pelabresib	Ae(8) and fe of pelabresib excreted into urine	24 hours
Secondary	Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)	Safety: TEAEs and treatment-emergent SAEs	12 months