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Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Primary Purpose

Advanced Malignancies, Solid Tumor, Hematological Malignancy

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pelabresib
Sponsored by
Constellation Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignancies focused on measuring Pelabresib, CPI 0610

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gabrail Cancer Center Research
  • Gettysburg Cancer Center
  • Start Mountain Region
  • Hight Technology Hospital Medcenter
  • K. Eristavi National Center of Experimental and Clinical Surgery
  • Simon Khechinashvili University Hospital
  • Barcelona HM Nou Delfos
  • Madrid - FJD
  • START CIOCC Hospital HM Sanchinarro
  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Run-In Food Effect Period

Continuous Treatment Period

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2022
Last Updated
March 9, 2023
Sponsor
Constellation Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05391022
Brief Title
Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
February 16, 2023 (Actual)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Constellation Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignancies, Solid Tumor, Hematological Malignancy
Keywords
Pelabresib, CPI 0610

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Run-In Food Effect Period
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous Treatment Period
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Pelabresib
Other Intervention Name(s)
CPI 0610
Intervention Description
Pelabresib monohydrate tablets
Primary Outcome Measure Information:
Title
Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay
Description
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
Title
Run-In Food Effect Period: maximal plasma concentration (Cmax) based on pelabresib concentrations in plasma measured using validated plasma assay
Description
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
Title
Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay
Description
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
Title
Continuous Treatment Period: Changes in QT and QTc intervals
Description
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 Outcome Measure Information:
Title
-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib
Description
Ae(∞) and fe of pelabresib excreted into urine
Time Frame
24 hours
Title
Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Description
Safety: TEAEs and treatment-emergent SAEs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Start Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Facility Name
Hight Technology Hospital Medcenter
City
Batumi
Country
Georgia
Facility Name
K. Eristavi National Center of Experimental and Clinical Surgery
City
Tbilisi
Country
Georgia
Facility Name
Simon Khechinashvili University Hospital
City
Tbilisi
Country
Georgia
Facility Name
Barcelona HM Nou Delfos
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Madrid - FJD
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
START CIOCC Hospital HM Sanchinarro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

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Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

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