Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Sponsor

Constellation Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05391022

Collaborator

(none)

Enrollment

Locations

Arms

20.1

Anticipated Duration (Months)

10.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies Solid Tumor Hematological Malignancy	Drug: Pelabresib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 26, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

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

Outcome Measures

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 [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
Run-In Food Effect Period: maximal plasma concentration (Cmax) based on pelabresib concentrations in plasma measured using validated plasma assay [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
Run-In Food Effect Period: Time to maximal plasma concentration (Tmax) based on pelabresib concentrations in plasma measured using validated plasma assay [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
Continuous Treatment Period: Changes in QT and QTc intervals [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 Outcome Measures

-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib [24 hours]
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) [12 months]
Safety: TEAEs and treatment-emergent SAEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 <1

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gabrail Cancer Center Research	Canton	Ohio	United States	44718
2	Gettysburg Cancer Center	Gettysburg	Pennsylvania	United States	17325
3	Start Mountain Region	West Valley City	Utah	United States	84119

Sponsors and Collaborators

Constellation Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Constellation Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05391022

Other Study ID Numbers:

CPI 0610-05

First Posted:

May 25, 2022

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Constellation Pharmaceuticals

Pelabresib

CPI 0610

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Jun 13, 2022