Status:

TERMINATED

A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma

Lead Sponsor:

Celgene

Conditions:

Glioblastoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 diagn...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 9 2024

Estimated Enrollment :

184 Patients enrolled

Trial Details

Trial ID

NCT04324840

Start Date

July 10 2020

End Date

July 9 2024

Last Update

July 26 2024

Active Locations (29)

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Page 1 of 8 (29 locations)

1

Local Institution - 800

New York, New York, United States, 10075

2

Local Institution - 503

Aalborg, Denmark, 9100

3

Local Institution - 501

Copenhagen, Denmark, 2100

4

Local Institution - 500

Odense, Denmark, 5000

A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma | DecenTrialz