Advanced Solid TumorsPhase 1NCT05678283
A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors
A Phase 1 study testing [14C]CC-90010 and CC-90010 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 1 site in Spain.
Trial summary
The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- [14C]CC-90010 and CC-90010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2023to 29 Apr 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males ≥ 18 years of age
- Has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Who cannot join
- Persistent diarrhea National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 2
- History of concurrent second cancers requiring active and ongoing systemic treatment
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors
The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- [14C]CC-90010, CC-90010
- Keywords
- CC-90010, Neoplasms, Solid Tumors, [14C]CC-90010, BMS-986378, BET Inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]CC-90010Drug
Specified dose on specified days
CC-90010Drug
Also called BMS-986378
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: CC-90010 followed by [14C]CC-90010 | Experimental | Not described Receives: Drug: [14C]CC-90010; Drug: CC-90010 |
| Part 2: CC-90010 | Experimental | Not described Receives: Drug: CC-90010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable)
Measured: Up to 26 Days
Cumulative elimination of total [14C]-radioactivity (as a fraction of the radioactive dose) in urine and feces (and vomit, if applicable)
Measured: Up to 14 Days
Total [14C]-radioactivity whole blood to plasma ratios
Measured: Up to 26 Days
Peak plasma drug concentration (Cmax)
Measured: Up to 26 Days
Time to peak plasma drug concentration (Tmax)
Measured: Up to 26 Days
Area under the concentration-time curve from time zero to time the time of the last measurable concentration (AUC[0-T])
Measured: Up to 26 Days
Secondary outcomes (6)
Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces
Measured: Up to 26 Days
Number of participants with adverse events (AEs)
Measured: Up to 26 Months
Number of participants with physical examination abnormalities
Measured: Up to 26 Months
Number of participants with vital sign abnormalities
Measured: Up to 26 Months
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 26 Months
Number of participants with clinical laboratory abnormalities
Measured: Up to 26 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start9 Jan 2023 (estimated)
- Primary completion29 Apr 2024 (estimated)
- Study completion29 Apr 2024 (estimated)
Why it stopped: Business Objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678283
- Sponsor's protocol ID
- CA076-001
- Other IDs
- 2021-005203-13
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05678283
- Acronym / sponsor ID
- CA076-001
- Conditions
- Advanced Solid Tumors
- Keywords
- CC-90010, Neoplasms, Solid Tumors, [14C]CC-90010, BMS-986378, BET Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Objectives have changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (estimated)
- Primary completion
- 29 Apr 2024 (estimated)
- Study completion
- 29 Apr 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: CC-90010 followed by [14C]CC-90010 | Experimental | Drug: [14C]CC-90010, Drug: CC-90010 |
| Part 2: CC-90010 | Experimental | Drug: CC-90010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males ≥ 18 years of age
- Has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Key exclusion criteria (3 listed)
- Persistent diarrhea National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 2
- History of concurrent second cancers requiring active and ongoing systemic treatment
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| [14C]CC-90010Specified dose on specified days | Drug | Part 1: CC-90010 followed by [14C]CC-90010 |
| CC-90010Also: BMS-986378Specified dose on specified days | Drug | Part 1: CC-90010 followed by [14C]CC-90010, Part 2: CC-90010 |
Primary outcome
Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable)
Time frame: Up to 26 Days
Cumulative elimination of total [14C]-radioactivity (as a fraction of the radioactive dose) in urine and feces (and vomit, if applicable)
Time frame: Up to 14 Days
Total [14C]-radioactivity whole blood to plasma ratios
Time frame: Up to 26 Days
Peak plasma drug concentration (Cmax)
Time frame: Up to 26 Days
Time to peak plasma drug concentration (Tmax)
Time frame: Up to 26 Days
Area under the concentration-time curve from time zero to time the time of the last measurable concentration (AUC[0-T])
Time frame: Up to 26 Days
6 secondary outcomes
Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces
Time frame: Up to 26 Days
Number of participants with adverse events (AEs)
Time frame: Up to 26 Months
Number of participants with physical examination abnormalities
Time frame: Up to 26 Months
Number of participants with vital sign abnormalities
Time frame: Up to 26 Months
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 26 Months
Number of participants with clinical laboratory abnormalities
Time frame: Up to 26 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.
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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]CC-90010 and CC-90010 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 1 site in Spain.
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 3 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: withdrawn, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable) (time frame: Up to 26 Days). The study lists 6 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 17 Apr 2024.