Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Part of paid clinical trials in Canton, Ohio.

Sponsor
Constellation Pharmaceuticals
Study ID
NCT05391022
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignancies
  • Hematological Malignancy
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jul 20, 2021
Status verified
Jul 2025
Primary completion
Mar 8, 2023
Completion
Feb 29, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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).

Primary Outcome Measure

Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay [ Time Frame: 21 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Gabrail Cancer Center ResearchCantonOhio44718-
Gettysburg Cancer CenterGettysburgPennsylvania17325-
Start Mountain RegionWest Valley CityUtah84119-

Find similar trials in Canton, OH

By research site
Gabrail Cancer Center Research· Canton, OHGettysburg Cancer Center· Gettysburg, PAStart Mountain Region· West Valley City, UT

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