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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/10/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/10/2020.

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

Clinicaltrials.gov identifier NCT03345095

Recruitment Status Recruiting

First Posted November 17, 2017

Last update posted June 17, 2019

Study Description

Brief summary:

The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

  • Condition or Disease:Newly Diagnosed Glioblastoma
  • Intervention/Treatment: Drug: Marizomib
    Drug: Temozolomide
    Radiation: radiotherapy
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 750 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma
  • Actual Study Start Date: July 2018
  • Estimated Primary Completion Date: July 2022
  • Estimated Study Completion Date: July 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Experimental Arm
Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib
Drug: Marizomib
Intravenous administration of Marizomib

Drug: Temozolomide
Oral Administration of Temozolomide

Radiation: radiotherapy
60 Gy in 30 fractions over 6 weeks
Active Comparator: Standard Arm
Radiotherapy + Temozolomide followed by adjuvant Temozolomide
Drug: Temozolomide
Oral Administration of Temozolomide

Radiation: radiotherapy
60 Gy in 30 fractions over 6 weeks
Outcome Measures
  • Primary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: From the date of randomization up to the date of death, assessed up to 49 months ]
  • Secondary Outcome Measures: 1. Progression Free Survival (PFS) [ Time Frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months ]
  • 2. Health-related Quality of life (HRQol) [ Time Frame: From randomization until progression, assessed up to 49 months ]
    HRQoL will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3.
  • 3. Mini Mental State Examination (MMSE) [ Time Frame: From the date of randomization until end of treatment, assessed up to 49 months ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)

- Tumor resection (gross total or partial), or biopsy only

- Availability of FFPE tumor block or 24 unstained slides for MGMT analysis

- Patient must be eligible for standard TMZ/RT + TMZ

- Karnofsky performance score (KPS) ≥ 70

- Recovered from effects of surgery, postoperative infection and other complications of
surgery (if any)

- The patient is at least 18 years of age on day of signing informed consent

- Stable or decreasing dose of steroids for at least 1 week prior to inclusion

- The patient has a life expectancy of at least 3 months

- Patient has undergone a brain MRI within 14 days of randomization but after
intervention (resection or biopsy)

- The patient shows adequate organ functions as assessed by the specified laboratory
values within 2 weeks prior to randomization defined as adequate bone marrow, renal
and hepatic function within the following ranges:

- WBC ≥ 3×10*9/L

- ANC ≥ 1.5×10*9/L

- Platelet count of ≥ 100×10*9/L independent of transfusion

- Hemoglobin ≥ 10 g/dl

- Total Bilirubin ≤ 1.5 ULN

- ALT, AST, alkaline phosphatase (ALP) ≤ 2.5 × ULN

- Serum creatinine 30 mL/min(using the
Cockcroft-Gault formula)

- Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy
test within 7 days prior to the first dose of study treatment.

- Patients of childbearing / reproductive potential must agree to use adequate birth
control measures, as defined by the investigator, during the study treatment period
and for at least 6 months after the last study treatment. A highly effective method of
birth control is defined as those which result in low failure rate (i.e. less than 1
percent per year) when used consistently and correctly. Patients must also agree not
to donate sperm during the study and for 6 months after receiving the last dose of
study treatment.

- Women who are breast feeding must agree to discontinue nursing prior to the first dose
of study treatment and until 6 months after the last study treatment.

- Ability to take oral medication

- Ability to understand the requirements of the study, provide written informed consent
and authorization of use and disclosure of protected health information, and agree to
abide by the study restrictions and return for the required assessments.

- Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.

Contacts and Locations
Contacts

Contact: EORTC +3227741611 eortc@eortc.org

Locations
Show 55 Study Locations
Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Celgene

Canadian Cancer Trials Group

Investigators

Principal Investigator: Patrick Roth EORTC Study Coordinator

More Information
  • Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
  • ClinicalTrials.gov Identifier: NCT03345095 History of Changes
  • Other Study ID Numbers: EORTC-BTG-1709
  • First Posted: November 17, 2017 Key Record Dates
  • Last Update Posted: June 17, 2019
  • Last Verified: January 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC: Marizomib
    Temozolomide
    Glioblastoma
    Phase III
  • Additional relevant MeSH terms: Glioblastoma