Phase 2
N=34
A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma
Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02315534 ↗Enrolled (actual)
34
Serious AEs
23.5%
Results posted
Sep 2021
Primary outcome: Primary: Dose-limiting Toxicities (DLTs) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BBI608 (Drug); Temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-limiting Toxicities (DLTs) |
0; 0 | — |
| PRIMARY Progression Free Survival (PFS)-6 |
28.07 | — |
| SECONDARY Progression Free Survival (PFS)-12 |
16.84 | — |
| SECONDARY Overall Survival (OS) |
8.05 | — |
| SECONDARY Disease Control Rate (DCR) |
30 | — |
| SECONDARY Overall Response Rate (ORR) |
3 | — |
| SECONDARY Pharmacokinetic Profile of BBI608 and Temozolomide When Administered in Combination With Temozolomide as Assessed by the Area Under the Curve |
4820; 4200 | — |
| SECONDARY Pharmacodynamic Activity of BBI608 When Administered in Combination With Temozolomide as Assessed by Tumor Biopsy and Cancer Stem Cell Assays as Well as the Concentration of Study Drug in Tumors |
19; 2; 2 | — |
Summary
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.
Eligibility Criteria
Major Eligibility Criteria
- Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements.
- 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
- Previously received standard front-line GBM treatment including maximal surgical resection followed by external beam radiation therapy.
- Patients may or may not be candidates for repeat surgical resection of the recurrent/progressed GBM.
- Patients must have unequivocal evidence of tumor recurrence/progression by MRI at a minimum of 12 weeks following completion of chemoradiation or radiation therapy.
- Patients must have measurable or non-measurable disease by response assessment in neuro-oncology Response Assessment in Neuro-oncology (RANO) criteria
Data sourced from ClinicalTrials.gov (NCT02315534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.