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CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma

A Phase 1, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects With Progressive or Recurrent Who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection

NCT04047303•Celgene

View on ClinicalTrials.gov

Summary

CC-90010-GBM-001 is a multi-center, open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD) and CNS penetration of CC-90010 following short-term interval therapy (4 daily doses ) prior to surgery, in subjects with progressive or recurrent WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and recurrent Glioblastoma who have failed radiation and chemotherapy, and who are candidates for surgical tumor resection as part of their salvage regimen (planned salvage resection).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must satisfy the following criteria to be enrolled in the study:
•1. Men and women ≥ 18 years of age,) with recurrent or progressive WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma or recurrent WHO Grade IV Glioblastoma .
•2. Subjects must have previously completed standard or a hypofractionated course of radiation therapy and have been exposed to procarbazine, lomustine and vincristine (for Grade II Astrocytoma), including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy, with radiation completed \> 12 weeks prior to the first CC-90010 dose (Day 1).
•3. Subject must be in first or second recurrence.
•4. Subject must have archival tumor tissue suitable for genetic testing and must give permission to access and test the tissue.
•5. Subject is considered an appropriate candidate for surgical resection of the recurrent tumor tissue (salvage resection).
•6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
•7. Subject must meet laboratory values at screening:
•* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L without growth factor support for 7 days (14 days if subject received pegfilgrastim).
•* Hemoglobin (Hgb) ≥10 g/dL
+8 more criteria

Exclusion Criteria

•The presence of any of the following will exclude a subject from enrollment:
•1. Subject has received anti-cancer therapy (either approved or investigational) within ≤ 4 weeks (6 weeks for nitrosoureas) or 5 half-lives, whichever is shorter, prior to starting CC-90010. If subject received prior immunotherapy (immune checkpoint inhibitor, vaccine, etc.), a 2 week wash-out is required. For a subject treated with the Optune-TTF device, a 2 day period without use is required.
•2. Toxicities resulting from prior chemotherapy, surgery, or radiotherapy must have resolved to ≤ NCI CTCAE (version 5.0) Grade 1 prior to starting CC-90010 treatment (with the exception of Grade 3 alopecia).
•3. Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to starting CC-90010 or subject who has not recovered from surgery.
•4. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of CC-90010.
•5. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
•6. Evidence of CNS hemorrhage on baseline MRI or CT scan (except for post-surgical, asymptomatic Grade 1 hemorrhage that has been stable for at least 4 weeks).
•7. Subject who requires increasing doses of corticosteroids to treat symptomatic cerebral edema within 7 days of study therapy.
•8. Known symptomatic acute or chronic pancreatitis.
•9. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
+23 more criteria

Locations (4)

Local Institution - 101

Tampa, Florida, United States

Local Institution - 102

Boston, Massachusetts, United States

Local Institution - 302

Madrid, Spain

Local Institution - 301

Madrid, Spain

Key Dates

Start Date

January 2, 2020

Primary Completion Date

June 3, 2024

Completion Date

June 3, 2024

Last Updated

July 5, 2024

Enrollment

ACTUAL participants

Conditions

AstrocytomaGlioblastoma

Interventions

CC-90010

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

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