New York, New York 10016


Purpose:

This is an open label, multi-center, phase 1 safety run-in and phase 2 study of BBI608 in combination with temozolomide in patients with recurrent or progressive glioblastoma who have not received prior bevacizumab therapy.


Study summary:

In arm A, patients who are candidates for surgical resection will receive BBI608 as monotherapy prior to resection, followed by post-operative BBI608 administered in combination with temozolomide. In arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, in combination with temozolomide. In the phase 1/DLT cohort portion of this study, pharmacokinetics will be evaluated for both arms A and B. Pharmacodynamics will be evaluated in all patients who undergo surgical resection.


Criteria:

Major Eligilbility Criteria 1. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements. 2. A histologically confirmed supratentorial glioblastoma (GBM) at first recurrence/progression (except for transformation from previous low grade glioma) following standard front-line therapy, for which treatment with temozolomide (TMZ) would be acceptable as determined by the Investigator 3. Previously received standard front-line GBM treatment including maximal surgical resection followed by external beam radiation therapy. 4. Patients may or may not be candidates for repeat surgical resection of the recurrent/progressed GBM. 5. Patients must have unequivocal evidence of tumor recurrence/progression by MRI at a minimum of 12 weeks following completion of chemoradiation or radiation therapy. 6. Patients must have measurable or non-measurable disease by response assessment in neuro-oncology (RANO) criteria 7. ≥18 years of age. 8. Eastern Oncology Cooperative Group (ECOG) performance status of 0 or 1


NCT ID:

NCT02315534


Primary Contact:

Boston Biomedical
Phone: 617-674-6800


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States

Sunita Latchman, Regulatory Specialist
Phone: 929-455-2432
Email: sunita.latchman@nyumc.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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