Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2024-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Advanced Malignancies Solid Tumor Hematological Malignancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pelabresib

Intervention Type DRUG

Pelabresib monohydrate tablets

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).

Group Type EXPERIMENTAL

Pelabresib

Intervention Type DRUG

Pelabresib monohydrate tablets

Interventions

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Pelabresib

Pelabresib monohydrate tablets

Intervention Type DRUG

Other Intervention Names

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CPI 0610

Eligibility Criteria

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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