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Administration of CC-90010 for Astrocytoma

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 days following c1d1
Awards & highlights

Study Summary

This trialstudies the effects of a medicine in people with a certain type of brain tumor who have failed radiation and chemo and are candidates for surgical tumor resection.

Who is the study for?
Adults with recurrent WHO Grade II-IV Astrocytoma or Glioblastoma, who've had prior radiation and chemotherapy, are eligible for this trial. They must be in their first or second recurrence, have stable organ function as indicated by specific blood tests, agree to use contraception during the study and up to several months after, and be suitable candidates for surgical tumor removal.Check my eligibility
What is being tested?
The trial is testing CC-90010's ability to penetrate the brain and its effects on patients' tumors before surgery. Participants will receive four daily doses of CC-90010 leading up to their planned tumor resection surgery.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include typical reactions related to cancer medications such as nausea, fatigue, risk of infection due to lowered blood counts, liver issues (as monitored by AST/ALT levels), kidney function changes (monitored by creatinine/GFR), and possibly others based on individual patient response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 days following c1d1
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 days following c1d1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neoplasms
Pharmacokinetics - AUC24
Pharmacokinetics - AUClast
+5 more
Secondary outcome measures
Adverse Events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of CC-90010Experimental Treatment1 Intervention
During the preoperative period, all subjects will be given a course of orally administrated CC-90010 at 30 mg once daily for 4 consecutive days on Cycle 1 Day 1 to Day 4. The last CC-90010 dose (Day 4) will be administrated 6-24 hours prior to brain tumor resection. Following recovery from surgery and a minimum of 4 weeks from the first CC-90010 dose (Cycle 1 Day 1), subjects who are fit to continue study treatment my restart CC-90010 on Day 1 of Cycle 2 at 45 mg given orally once daily for 4 consecutive days followed by 24 consecutive days off (4 days on/24 days off), in each 28 day cycle.

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Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,951 Total Patients Enrolled
Zariana Nikolova, MD, PhDStudy DirectorCelgene Corporation
5 Previous Clinical Trials
505 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,477 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma
2020. "CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04047303.
All > Anaplastic Ependymoma > Anaplastic Astrocytoma
~0 spots leftby May 2024
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