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Completed

NCT Number: NCT05391022

Study Evaluating Food Effect and 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

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Key information

Conditions

Advanced Malignancies Hematologic Diseases Hematologic Neoplasms Hematological Malignancy Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hight Technology Hospital Medcenter, Batumi, Georgia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelabresib

Drug

Pelabresib monohydrate tablets

Other names: CPI 0610

Primary outcomes

  1. Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay

    Time frame: 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

  2. Run-In Food Effect Period: maximal plasma concentration (Cmax) based on pelabresib concentrations in plasma measured using validated plasma assay

    Time frame: 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

  3. Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay

    Time frame: 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

  4. Continuous Treatment Period: Changes in QT and QTc intervals

    Time frame: 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

Secondary outcomes

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

    Time frame: 24 hours

    Ae(∞) and fe of pelabresib excreted into urine

  2. Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 12 months

    Safety: TEAEs and treatment-emergent SAEs

Sponsors and collaborators

Lead sponsor

Constellation Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 25, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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