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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02315534
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc

Tracking Information
First Submitted Date  ICMJE December 9, 2014
First Posted Date  ICMJE December 12, 2014
Last Update Posted Date October 1, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date October 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs) (Phase 1 portion) [ Time Frame: 4 weeks ]
  • Progression Free Survival (PFS)-6 (phase 2 portion) [ Time Frame: 6 months ]
    Defined as the proportion of patients with progression free survival (PFS) i.e. absence of documented objective progression or death at 6 months after enrollment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • Progression Free Survival (PFS) [ Time Frame: 24 months ]
    Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.
  • Overall Survival (OS) [ Time Frame: 24 months ]
    Defined as the time from enrollment to death due to any cause.
  • Disease Control Rate (DCR) [ Time Frame: 4 weeks ]
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on the Response Assessment in Neuro-Oncology (RANO) criteria.
  • Objective Response Rate (ORR) [ Time Frame: 4 weeks ]
    Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RANO criteria.
  • Pharmacokinetic profile of BBI608 and temozolomide when administered in combination with temozolomide as assessed by maximum plasma concentration and area under the curve [ Time Frame: On Day 1 and Day 5 after the first dosing, prior to dosing and 1, 2, 3, 5, 5h40m (day 1 only), 6, 7, 8 and 24 hours after first dose of BBI608 ]
    Blood sampling to assess the pharmacokinetic profile (maximum plasma concentration and area under the curve) of BBI608 and temozolomide.
  • 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 [ Time Frame: At the time of surgical resection ]
    Tumor samples to provide information of the biomarkers by histopathology and Cancer Stem Cell assays as well as the concentration of study drug in tumors.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma
Official Title  ICMJE A Phase Ib/II Clinical Study of BBI608 in Combination With Temozolomide for Adult Patients With Recurrent or Progressed Glioblastoma
Brief 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.
Detailed 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/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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: BBI608

    In arm A, BBI608 will be administered at the RP2D twice daily for 7(±2) days prior to planned surgical resection or biopsy of recurrent GBM. Upon the clinical recovery of the patient and at a time between 15-28 days after surgery, BBI608 will be administered orally, daily, each day of a 28 day cycle in combination with temozolomide.

    In arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, each day of a 28 day cycle at the RP2D in combination with temozolomide.

    Other Names:
    • Napabucasin
    • BB608
    • BBI-608
  • Drug: Temozolomide
    Temozolomide (TMZ) will be administered orally, once daily, at a dose of 150 mg/m^2 daily on days 1 through 5 of each 28-day study cycle. The dose of temozolomide can be increased to 200 mg/m^2 as per standard TMZ dosing guidelines for patients who complete at least one cycle at 150 mg/m^2.
    Other Name: Temodar
Study Arms  ICMJE
  • Experimental: Arm A
    Patients for whom surgery is recommended as part of treatment for recurrent Glioblastoma.
    Interventions:
    • Drug: BBI608
    • Drug: Temozolomide
  • Experimental: Arm B
    Patients for whom surgery is not recommended as part of the treatment for recurrent Glioblastoma.
    Interventions:
    • Drug: BBI608
    • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
60
Actual Study Completion Date  ICMJE June 24, 2019
Actual Primary Completion Date October 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315534
Other Study ID Numbers  ICMJE BBI608-251
BBI608-201GBM ( Other Identifier: Boston Biomedical, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Biomedical, Inc
Study Sponsor  ICMJE Boston Biomedical, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boston Biomedical, Inc
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP