Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Study Overview
=================
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

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

Conditions
-----------------
Advanced Malignancies, Solid Tumor, Hematological Malignancy

Intervention / Treatment
-----------------
* Drug: Pelabresib


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Run-In Food Effect Period<br>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<br>* Pelabresib monohydrate tablets<br>* Other names: CPI 0610;|
| Experimental: Continuous Treatment Period<br>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<br>* Pelabresib monohydrate tablets<br>* Other names: CPI 0610;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib | Ae(∞) and fe of pelabresib excreted into urine | 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 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelabresib, CPI 0610