- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT04047303
Recruitment Status Recruiting
First Posted August 6, 2019
Last update posted July 24, 2020
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).
|Experimental: Administration of CC-90010
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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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 109/L without growth factor support for 7
days (14 days if subject received pegfilgrastim).
- Hemoglobin (Hgb) ≥10 g/dL
- Platelet count (plt) ≥150 x 109/L
- Serum potassium concentration within normal range, or correctable with
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x Upper
Limit of Normal (ULN).
- Serum total bilirubin ≤ 1.5 x ULN.
- Serum creatinine ≤ 1.5 x ULN or measured glomerular filtration rate (GFR) ≥ 50
mL/min/1.73 m2 using an exogenous filtration marker such as iohexol, inulin, 51Cr
EDTA or 1 iothalamate, or creatinine clearance of ≥ 50 mL/min using
- Serum albumin > 3.5 g/dL
- PT (or INR) and APTT within normal range
8. Females and males must agree to contraceptive methods and avoid conceiving throughout
study and up to 3 months (females) and 106 days (males) following last dose of
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
- LVEF < 45% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO). - Complete left bundle branch or bifascicular block. - Congenital long QT syndrome. - Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation. - QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings); a marked baseline prolongation of QT/QTc interval, using Fridericia´s QT correction formula. - History of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome. - Use of concomitant medications that prolong the QT/QTc interval. - Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting CC-90010. - Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg). 10. Pregnant or nursing females. 11. Known HIV infection. 12. Known chronic active hepatitis B or C virus (HBV, HCV) infection. 13. Subject with a requirement for ongoing treatment with therapeutic dosing of anticoagulants or for ongoing prophylactic anticoagulation. Low dose low molecular weight heparin for catheter maintenance is allowed. 14. History of concurrent second cancers requiring active, ongoing systemic treatment. 15. Evidence of history of bleeding diathesis. 16. Subject with known prior episodes of non-arteritic anterior ischemic optic neuropathy (NAION) should be excluded from the study. CC-90010 should be used with caution in subjects with retinitis pigmentosa. 17. Subject with poor bone marrow reserve as assessed by Investigator such as in the following condition: - Requiring regular hematopoietic support
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 firstname.lastname@example.org
United States, Florida
Mayo Clinic - Jacksonville
United States, Florida
Moffit Cancer Center
United States, Massachusetts
Dana Farber Cancer Institute
Hospital Universitario Fundacion Jimenez Diaz
Hospital Universitario 12 de Octubre
Study Director: Zariana Nikolova, MD, PhD Celgene Corporation