Clinical Trial Details
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NCT02315534 : A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
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
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