A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma

Sumitomo Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glioblastoma

Treatments: Drug: Temozolomide; Drug: BBI608

Study type: Interventional

Funder types: Industry

Identifiers

NCT02315534

BBI608-251

BBI608-201GBM (Other Identifier)

Details and patient eligibility

About

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.

Full description

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/dose-limiting toxicity (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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Eligibility 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 Response Assessment in Neuro-oncology (RANO) criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Arm A

Experimental group

Description:

Patients for whom surgery is recommended as part of treatment for recurrent Glioblastoma.

Treatment:

Drug: BBI608

Drug: Temozolomide

Arm B

Experimental group

Description:

Patients for whom surgery is not recommended as part of the treatment for recurrent Glioblastoma.

Treatment:

Drug: BBI608

Drug: Temozolomide