NCT05391022

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2021

Typical duration for phase_1

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

May 5, 2022

Last Update Submit

July 23, 2025

Conditions

Advanced MalignanciesSolid TumorHematological Malignancy

Keywords

PelabresibCPI 0610

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

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

    24 hours

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

    12 months

Study Arms (2)

Run-In Food Effect Period

EXPERIMENTAL

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

Continuous Treatment Period

EXPERIMENTAL

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

Interventions

PelabresibDRUG

Pelabresib monohydrate tablets

Also known as: CPI 0610
Continuous Treatment PeriodRun-In Food Effect Period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic or active conditions and/or concomitant medication use that would prohibit treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Start Mountain Region

West Valley City, Utah, 84119, United States

Location

Hight Technology Hospital Medcenter

Batumi, Georgia

Location

K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia

Location

Simon Khechinashvili University Hospital

Tbilisi, Georgia

Location

Barcelona HM Nou Delfos

Barcelona, 08023, Spain

Location

Madrid - FJD

Madrid, 28040, Spain

Location

START CIOCC Hospital HM Sanchinarro

Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 25, 2022

Study Start

July 20, 2021

Primary Completion

March 8, 2023

Study Completion

February 29, 2024

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations

US(3)ES(4)GE(3)