Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Constellation Pharmaceuticals35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Malignancies Solid Tumor Hematological Malignancy

Interventions

PelabresibDRUG

Pelabresib monohydrate tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Gabrail Cancer Center Research

Canton, Ohio, United States

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Start Mountain Region

West Valley City, Utah, United States

Hight Technology Hospital Medcenter

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months

Secondary Outcomes

-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib

Ae(∞) and fe of pelabresib excreted into urine

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.