Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Advanced Malignancies; Hematological Malignancy
• Intervention / Treatment: Drug: Pelabresib

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Information; Phone Number: +1 (844) 667-1992; Email: medinfo@morphosys.com

Study Locations

• Georgia
  • Batumi, Georgia
    • Hight Technology Hospital Medcenter
  • Tbilisi, Georgia
    • Simon Khechinashvili University Hospital
  • Tbilisi, Georgia
    • K. Eristavi National Center of Experimental and Clinical Surgery
• Spain
  • Barcelona, Spain, 08023
    • Barcelona HM Nou Delfos
  • Madrid, Spain, 28040
    • Madrid - FJD
  • Madrid, Spain
    • START CIOCC Hospital HM Sanchinarro
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
• United States
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
  • Utah
    • West Valley City, Utah, United States, 84119
      • START Mountain Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Run-In Food Effect Period; 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.	Drug: Pelabresib; Pelabresib monohydrate tablets; Other Names: CPI 0610
Experimental: Continuous Treatment Period; 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).	Drug: Pelabresib; Pelabresib monohydrate tablets; Other Names: CPI 0610

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Safety: TEAEs and treatment-emergent SAEs	12 months

Collaborators and Investigators

• Sponsor: Constellation Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): March 8, 2023
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pelabresib; CPI 0610
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: CPI 0610-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No