Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Constellation Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Advanced Malignancies; Hematological Malignancy

Treatments: Drug: Pelabresib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05391022

CDAK539A12106 (Other Identifier)

2022-000896-38 (EudraCT Number)

CPI 0610-05

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Run-In Food Effect Period

Experimental group

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.

Treatment:

Drug: Pelabresib

Continuous Treatment Period

Experimental group

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).

Treatment:

Drug: Pelabresib