GlioblastomaPhase 1NCT04324840
A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
A Phase 1 study testing CC-90010, Temozolomide and Radiotherapy in people with Glioblastoma, run by Celgene at 29 sites in 7 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- CC-90010, Temozolomide and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 10 Jul 2020to 9 Jul 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
- Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
- O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
- Karnofsky performance status of ≥70
Who cannot join
- Indeterminate MGMT promoter methylation status
- Biopsy only of glioblastoma (GBM) at surgery, defined as < 20% resection of enhancing tumor
- Any known metastatic extracranial or leptomeningeal disease
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Spain12 sites
Local Institution - 311
A Coruña, 15006
Local Institution - 306
Barcelona, 08003
Local Institution - 302
Barcelona, 08035
Local Institution - 303
Barcelona, 08036
Local Institution - 307
Hospitalet de Llobregat, Barcelona, 08907
Local Institution - 304
Madrid, 28034
Local Institution - 301
Madrid, 28040
Local Institution - 300
Madrid, 28041
Local Institution - 310
Pamplona, 31008
Local Institution - 309
Seville, 41013
Local Institution - 305
Valencia, 46026
Local Institution - 312
Vigo, 36312
Italy4 sites
Local Institution - 202
Milan, 20089
Local Institution - 201
Milan, 20132
Local Institution - 204
Padova, 35128
Local Institution - 200
Verona, 37126
Netherlands4 sites
Local Institution - 405
Amsterdam, 1066 CX
Local Institution - 408
Leiden, South Holland, 2333 ZA
Local Institution - 400
Rotterdam, 3015 GD
Local Institution - 401
Utrecht, 3584 CX
Sweden4 sites
Local Institution - 702
Gothenburg, 413 45
Local Institution - 701
Lund, 222 41
Local Institution - 700
Solna, 171 64
Local Institution - 703
Uppsala, 75185
Denmark3 sites
Local Institution - 503
Aalborg, 9100
Local Institution - 501
Copenhagen, 2100
Local Institution - 500
Odense, 5000
About this study
Official title: A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM).
- Conditions
- Glioblastoma
- Being tested
- CC-90010, Temozolomide, Radiotherapy
- Keywords
- CC-90010, Temozolomide, Glioblastoma, NEWLY DIAGNOSED, Radiation therapy, Safety, Tolerability, MTD and RP2D
- Medical subject headings
- Glioblastoma, Metatropic dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90010Drug
Specified dose on specified days
TemozolomideDrug
Specified dose on specified days
RadiotherapyRadiation
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: CC-90010; Drug: Temozolomide; Radiation: Radiotherapy |
| Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) | Experimental | Not described Receives: Drug: CC-90010; Drug: Temozolomide; Radiation: Radiotherapy |
| Part B - Standard TMZ + RT | Other | Control Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Parts A and B
Measured: Up to 3 years
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0
Parts A and B
Measured: Up to 3 years
Incidence of dose-limiting toxicities (DLTs)
Part A
Measured: Up to 3 years
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)
Part A
Measured: Up to 3 years
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)
Part A
Measured: Up to 3 years
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ
Part A
Measured: Up to 3 years
RP2D of CC-90010 in combination with TMZ and RT
Part A
Measured: Up to 3 years
Median Progression-free survival (PFS) in Arm A vs Arm B
Part B
Measured: Up to 12 months
Hazard ratio for PFS in Arm A vs Arm B
Part B
Measured: Up to 12 months
Secondary outcomes (7)
Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause
Parts A and B
Measured: Up to 5 years
Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS
Parts A and B
Measured: Up to 5 years
Duration of therapy (DoT) in Arm A vs Arm B
Part B
Measured: Up to 5 years
Response by Response Assessment in Neuro-Oncology (RANO) criteria
Parts A and B
Measured: Up to 5 years
Pharmacokinetics - Maximum observed plasma concentration (Cmax)
Parts A and B
Measured: Up to 2 years
Pharmacokinetics - Area under the plasma concentration time-curve (AUC)
Parts A and B
Measured: Up to 2 years
Pharmacokinetics - Time to maximum plasma concentration (Tmax)
Parts A and B
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start10 Jul 2020
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT04324840
- Sponsor's protocol ID
- CC-90010-GBM-002
- Other IDs
- U1111-1248-0496, 2019-004122-25, 2019
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2020
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Publications
Moreno V, Manuel Sepulveda J, Reardon DA, Perez-Nunez A, Gonzalez Leon P, Hanna B, Filvaroff E, Aronchik I, Chang H, Amoroso B, Zuraek M, Sanchez-Perez T, Mendez C, Stephens D, Nikolova Z, Vogelbaum MA. Trotabresib, an oral potent bromodomain and extraterminal inhibitor, in patients with high-grade gliomas: A phase I, "window-of-opportunity" study. Neuro Oncol. 2023 Jun 2;25(6):1113-1122. doi: 10.1093/neuonc/noac263.
PubMed 36455228
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT04324840
- Acronym / sponsor ID
- CC-90010-GBM-002
- Conditions
- Glioblastoma
- Keywords
- CC-90010, Temozolomide, Glioblastoma, NEWLY DIAGNOSED, Radiation therapy, Safety, Tolerability, MTD and RP2D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 27 Mar 2020 (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 determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: CC-90010, Drug: Temozolomide, Radiation: Radiotherapy |
| Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) | Experimental | Drug: CC-90010, Drug: Temozolomide, Radiation: Radiotherapy |
| Part B - Standard TMZ + RT | Other | Radiation: RadiotherapyControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
- O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
- Karnofsky performance status of ≥70
Key exclusion criteria (4 listed)
- Indeterminate MGMT promoter methylation status
- Biopsy only of glioblastoma (GBM) at surgery, defined as < 20% resection of enhancing tumor
- Any known metastatic extracranial or leptomeningeal disease
- 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 |
|---|---|---|
| CC-90010Specified dose on specified days | Drug | Part A, Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) |
| TemozolomideSpecified dose on specified days | Drug | Part A, Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) |
| RadiotherapySpecified dose on specified days | Radiation | Part A, Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT), Part B - Standard TMZ + RT |
Primary outcome
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to 3 years
Parts A and B
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0
Time frame: Up to 3 years
Parts A and B
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 3 years
Part A
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)
Time frame: Up to 3 years
Part A
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)
Time frame: Up to 3 years
Part A
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ
Time frame: Up to 3 years
Part A
RP2D of CC-90010 in combination with TMZ and RT
Time frame: Up to 3 years
Part A
Median Progression-free survival (PFS) in Arm A vs Arm B
Time frame: Up to 12 months
Part B
Hazard ratio for PFS in Arm A vs Arm B
Time frame: Up to 12 months
Part B
7 secondary outcomes
Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause
Time frame: Up to 5 years
Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS
Time frame: Up to 5 years
Duration of therapy (DoT) in Arm A vs Arm B
Time frame: Up to 5 years
Response by Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: Up to 5 years
Pharmacokinetics - Maximum observed plasma concentration (Cmax)
Time frame: Up to 2 years
Pharmacokinetics - Area under the plasma concentration time-curve (AUC)
Time frame: Up to 2 years
Pharmacokinetics - Time to maximum plasma concentration (Tmax)
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 36455228Moreno V, Manuel Sepulveda J, Reardon DA, Perez-Nunez A, Gonzalez Leon P, Hanna B, Filvaroff E, Aronchik I, Chang H, Amoroso B, Zuraek M, Sanchez-Perez T, Mendez C, Stephens D, Nikolova Z, Vogelbaum MA. Trotabresib, an oral potent bromodomain and extraterminal inhibitor, in patients with high-grade gliomas: A phase I, "window-of-opportunity" study. Neuro Oncol. 2023 Jun 2;25(6):1113-1122. doi: 10.1093/neuonc/noac263.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-90010, Temozolomide and Radiotherapy in people with Glioblastoma, run by Celgene at 29 sites in 7 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 4 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: stopped early, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain, Italy, Netherlands, Sweden, Denmark and 2 more countries. 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 stopped early (reason given: Business objectives have changed). Results are not available in the source record.
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?
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (time frame: Up to 3 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324840, which also lists 1 linked publication.
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 26 Jul 2024.