Trial record 1 of 141 for:
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
A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
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| ClinicalTrials.gov Identifier: NCT04324840 |
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Recruitment Status :
Recruiting
First Posted : March 27, 2020
Last Update Posted : January 4, 2023
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma | Drug: CC-90010 Drug: Temozolomide Radiation: Radiotherapy | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 194 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 10, 2020 |
| Estimated Primary Completion Date : | September 12, 2023 |
| Estimated Study Completion Date : | March 5, 2025 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Temozolomide
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part A |
Drug: CC-90010
Specified dose on specified days Drug: Temozolomide Specified dose on specified days Radiation: Radiotherapy Specified dose on specified days |
| Experimental: Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) |
Drug: CC-90010
Specified dose on specified days Drug: Temozolomide Specified dose on specified days Radiation: Radiotherapy Specified dose on specified days |
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Part B - Standard TMZ + RT
Control
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Radiation: Radiotherapy
Specified dose on specified days |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 ]Parts A and B
- 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 ]Parts A and B
- Duration of therapy (DoT) in Arm A vs Arm B [ Time Frame: Up to 5 years ]Part B
- Response by Response Assessment in Neuro-Oncology (RANO) criteria [ Time Frame: Up to 5 years ]Parts A and B
- Pharmacokinetics - Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 2 years ]Parts A and B
- Pharmacokinetics - Area under the plasma concentration time-curve (AUC) [ Time Frame: Up to 2 years ]Parts A and B
- Pharmacokinetics - Time to maximum plasma concentration (Tmax) [ Time Frame: Up to 2 years ]Parts A and B
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324840
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain the NCT# and Site #. |
Locations
Show 55 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT04324840 |
| Other Study ID Numbers: |
CC-90010-GBM-002 U1111-1248-0496 ( Other Identifier: WHO ) 2019-004122-25 ( EudraCT Number ) |
| First Posted: | March 27, 2020 Key Record Dates |
| Last Update Posted: | January 4, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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/ |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Celgene:
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CC-90010 Temozolomide Glioblastoma NEWLY DIAGNOSED |
Radiation therapy Safety Tolerability MTD and RP2D |
Additional relevant MeSH terms:
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Temozolomide Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |