Advanced MalignanciesPhase 1NCT05391022
Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies
A Phase 1 study testing Pelabresib in people with Advanced Malignancies and Solid Tumor, run by Constellation Pharmaceuticals at 10 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Solid Tumor, Hematological Malignancy
- What is being tested?
- Pelabresib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 20 Jul 2021to 29 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic or active conditions and/or concomitant medication use that would prohibit treatment
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Spain4 sites
Barcelona HM Nou Delfos
Barcelona, 08023
Madrid - FJD
Madrid, 28040
START CIOCC Hospital HM Sanchinarro
Madrid
Hospital Universitario Virgen del Rocío
Seville, 41013
United States3 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Start Mountain Region
West Valley City, Utah, 84119
Georgia3 sites
Hight Technology Hospital Medcenter
Batumi
K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi
Simon Khechinashvili University Hospital
Tbilisi
About this study
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
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
- Being tested
- Pelabresib
- Keywords
- Pelabresib, CPI 0610
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelabresibDrug
Also called CPI 0610
Pelabresib monohydrate tablets
| Study group | Role | What they receive |
|---|---|---|
| Run-In Food Effect Period | Experimental | 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. Receives: Drug: Pelabresib |
| Continuous Treatment Period | Experimental | 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). Receives: Drug: Pelabresib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (2)
-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib
Ae(∞) and fe of pelabresib excreted into urine
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start20 Jul 2021
- Primary completion8 Mar 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Constellation Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391022
- Sponsor's protocol ID
- CPI 0610-05
- Other IDs
- 2022-000896-38, CDAK539A12106
- Status last verified
- Jul 2025
- First submitted
- 5 May 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05391022
- Acronym / sponsor ID
- CPI 0610-05
- Conditions
- Advanced Malignancies, Solid Tumor, Hematological Malignancy
- Keywords
- Pelabresib, CPI 0610
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Constellation PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Run-In Food Effect Period | Experimental | Drug: PelabresibUnblinded, 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. |
| Continuous Treatment Period | Experimental | Drug: PelabresibUnblinded, 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic or active conditions and/or concomitant medication use that would prohibit treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelabresibAlso: CPI 0610Pelabresib monohydrate tablets | Drug | Continuous Treatment Period, Run-In Food Effect Period |
Primary outcome
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
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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
-In Food Effect Period: Total amount (Ae[∞]) and fraction of dose (fe) of pelabresib
Time frame: 24 hours
Run-In Food Effect Period and Continuous Treatment Period: incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pelabresib in people with Advanced Malignancies and Solid Tumor, run by Constellation Pharmaceuticals at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, United States, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.