Study Description

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:Glioblastoma
• Intervention/Treatment: Drug: CC-90010
  Drug: Temozolomide
  Radiation: Radiotherapy
• Phase: Phase 1

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. 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
• Primary Outcome Measures: 2. Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0 [ Time Frame: Up to 3 years ]
  Parts A and B
• Primary Outcome Measures: 3. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 3 years ]
  Part A
• Primary Outcome Measures: 4. Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ) [ Time Frame: Up to 3 years ]
  Part A
• Primary Outcome Measures: 5. MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT) [ Time Frame: Up to 3 years ]
  Part A
• Primary Outcome Measures: 6. Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ [ Time Frame: Up to 3 years ]
  Part A
• Primary Outcome Measures: 7. RP2D of CC-90010 in combination with TMZ and RT [ Time Frame: Up to 3 years ]
  Part A
• Primary Outcome Measures: 8. Median Progression-free survival (PFS) in Arm A vs Arm B [ Time Frame: Up to 12 months ]
  Part B
• Primary Outcome Measures: 9. Hazard ratio for PFS in Arm A vs Arm B [ Time Frame: Up to 12 months ]
  Part B
• Secondary Outcome Measures: 1. 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
• Secondary Outcome Measures: 2. 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
• Secondary Outcome Measures: 3. Duration of therapy (DoT) in Arm A vs Arm B [ Time Frame: Up to 5 years ]
  Part B
• Secondary Outcome Measures: 4. Response by Response Assessment in Neuro-Oncology (RANO) criteria [ Time Frame: Up to 5 years ]
  Parts A and B
• Secondary Outcome Measures: 5. Pharmacokinetics - Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 2 years ]
  Parts A and B
• Secondary Outcome Measures: 6. Pharmacokinetics - Area under the plasma concentration time-curve (AUC) [ Time Frame: Up to 2 years ]
  Parts A and B
• Secondary Outcome Measures: 7. Pharmacokinetics - Time to maximum plasma concentration (Tmax) [ Time Frame: Up to 2 years ]
  Parts A and B

Eligibility Criteria

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

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT04324840 History of Changes
• Other Study ID Numbers: CC-90010-GBM-002, U1111-1248-0496, 2019-004122-25
• First Posted: March 27, 2020 Key Record Dates
• Last Update Posted: May 5, 2022
• Last Verified: May 2022

• 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: CC-90010
  Temozolomide
  Glioblastoma
  NEWLY DIAGNOSED Radiation therapy
  Safety
  Tolerability
  MTD and RP2D
• Additional relevant MeSH terms: Glioblastoma
  Astrocytoma
  Glioma
  Neoplasms, Neuroepithelial
  Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal
  Neoplasms by Histologic Type
  Neoplasms
  Neoplasms, Glandular and Epithelial
  Neoplasms, Nerve Tissue