Status:
COMPLETED
A Study in Subjects With Recurrent Malignant Glioma
Lead Sponsor:
Eisai Inc.
Conditions:
Glioma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
An open-label phase 2, multicenter study in participants with recurrent malignant glioma.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed diagnosis of Grade 3 or 4 malignant glioma.
- All subjects who have a first or second recurrence following primary management with surgical resection or biopsy, radiotherapy and up to 2 prior systemic treatments with addition of:
- No prior bevacizumab treatment is allowed for Cohort 1 and Cohort 2.
- Subjects must have disease progression following prior bevacizumab treatment for Cohort 3.
- For all cohorts, no prior anti-vascular endothelial growth factor (VEGF/VEGFR) therapy except for bevacizumab as specified above.
- Karnofsky score of 70% or greater.
- Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
- Adequate renal function, adequate bone marrow function, adequate blood coagulation function and adequate liver function, as defined in protocol.
- No evidence of hemorrhage on the baseline magnetic resonance imaging (MRI) scan other than in those subjects who are stable grade 1.
- Exclusion criteria:
- Females who are pregnant or breastfeeding.
- Subjects who received enzyme-inducing anti-epileptic agents within 14 days before the first dose of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).
- Active infection requiring intravenous antibiotics.
- Therapeutic anti-coagulation with warfarin, aspirin, nonsteroidal anti-inflammatory drugs or clopidogrel (low molecular weight heparin is acceptable).
- Subjects with 24-hour urine protein greater than or equal to 1 gm.
- Prior surgical resection within 4 weeks, or prior stereotactic biopsy within 2 weeks, of Screening Visit.
- Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there is biopsy-proven unequivocal viable tumor on histopathologic sampling.
- Prior chemotherapy (6 weeks for nitrosoureas), or any investigational agent within 4 weeks unless the subject has recovered from all anticipated toxicities associated with that therapy; prior bevacizumab therapy (Cohorts 1 and 2); for Cohort 3, prior bevacizumab therapy within 3 weeks.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II ; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.
- Prolongation of QTc interval to greater than 480 msec.
- Active hemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug.
Exclusion
Key Trial Info
Start Date :
November 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2014
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01137604
Start Date
November 9 2010
End Date
October 28 2014
Last Update
September 29 2022
Active Locations (5)
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1
Tampa, Florida, United States
2
Boston, Massachusetts, United States
3
Durham, North Carolina, United States
4
Calgary, Canada