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CC-90010 + Temozolomide for Glioblastoma

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status of ≥70

Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trialtests the safety of a new drug for treating glioblastoma, a type of brain cancer, with/without radiotherapy.

Who is the study for?

This trial is for adults with a new diagnosis of Grade IV glioblastoma, confirmed to be IDH-wild type. Participants must have a Karnofsky performance status of ≥70, indicating they are able to care for themselves. They need known MGMT promoter methylation status and should not have had just a biopsy with less than 20% tumor resection or any metastatic extracranial disease.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of CC-90010 combined with standard treatment temozolomide (TMZ), with or without radiotherapy (RT), in treating newly diagnosed glioblastoma. The goal is to see how well patients tolerate this combination and its impact on their cancer.See study design

What are the potential side effects?

Potential side effects may include those typical of chemotherapy and radiation such as nausea, fatigue, hair loss, skin irritation at the radiation site, low blood cell counts leading to increased infection risk, headaches, and potential neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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My brain tumor is a Grade IV Glioblastoma without IDH mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hazard ratio for PFS in Arm A vs Arm B

Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Incidence of dose-limiting toxicities (DLTs)

+6 more

Secondary outcome measures

Duration of therapy (DoT) in Arm A vs Arm 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

Pharmacokinetics - Area under the plasma concentration time-curve (AUC)

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B - Standard TMZ + RTExperimental Treatment1 Intervention

Control

Group II: Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)Experimental Treatment3 Interventions

Group III: Part AExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

Temozolomide

2010

Completed Phase 3

~1930

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

637 Previous Clinical Trials

129,320 Total Patients Enrolled

10 Trials studying Glioblastoma

1,934 Patients Enrolled for Glioblastoma

Zariana Nikolova, MD, PhDStudy DirectorCelgene

5 Previous Clinical Trials

315 Total Patients Enrolled

1 Trials studying Glioblastoma

20 Patients Enrolled for Glioblastoma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,510 Previous Clinical Trials

3,370,931 Total Patients Enrolled

8 Trials studying Glioblastoma

2,468 Patients Enrolled for Glioblastoma

Media Library

CC-90010 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04324840 — Phase 1

Glioblastoma Research Study Groups: Part A, Part B - Standard TMZ + RT, Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

Glioblastoma Clinical Trial 2023: CC-90010 Highlights & Side Effects. Trial Name: NCT04324840 — Phase 1

CC-90010 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04324840 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies can Adjuvant Treatment potentially ameliorate?

"Nitrosourea therapy, advance directives, and refractory cases of advanced mycosis fungoides can all be managed through the use of Adjuvant Treatment."

Answered by AI

Is Adjuvant Treatment a reliable and secure procedure to undergo?

"Our team at Power assigned Adjuvant Treatment a score of 1, as there is only limited evidence for its safety and efficacy at this early stage of the trial."

Answered by AI

Is this research program still open to new participants?

"According to clinicaltrials.gov, this study is presently accepting volunteers; the trial was initially registered on July 10th 2020 and most recently updated on March 1st 2023."

Answered by AI

Are there additional examples of Adjuvant Treatment being explored in research?

"Currently, there are 198 ongoing Adjuvant Treatment clinical trials around the globe. Of these trials, 22 are in their terminal phase while most of them originate from Seoul-Songpa. Across 4351 medical centres worldwide, patients can find a trial to join."

Answered by AI

How many participants are currently involved in the research?

"Affirmative, clinicaltrials.gov lists this medical trial as actively recruiting individuals from a single facility. The initial posting was on July 10th 2020 and the information has been revised for the last time on January 3rd 2023. Currently, 194 volunteers are being sought after."

Answered by AI

Is this trial the inaugural exploration of its type?

"Since its initial 2002 trial, sponsored by Schering-Plough and involving 60 patients, Adjuvant Treatment has seen 198 clinical trials in 874 cities across 36 countries. This research eventually culminated with the drug approval for Phase 2."

Answered by AI

With what goal is this investigation intended to achieve?

"This clinical study will determine the Maximum Tolerated Dose (MTD) of CC-90010 when taken in combination with Temozolomide (TMZ), in a span of up to 3 years. Secondary endpoints that are also evaluated include Progression-free survival, Cmax, and Plasma Concentration - all over Parts A & B."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04324840.

All > Glioblastoma New York > Glioblastoma Multiforme