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

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• Glioblastoma 1,917

Keywords

• Marizomib
• Temozolomide
• Glioblastoma
• Phase III

Eligibility criteria

Study arms

• Experimental
  Experimental Arm

  Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib

  Drug: Marizomib · Drug: Temozolomide · Radiation: radiotherapy

• Active comparator
  Standard Arm

  Radiotherapy + Temozolomide followed by adjuvant Temozolomide

  Drug: Temozolomide · Radiation: radiotherapy

Interventions

• DrugMarizomib

  Intravenous administration of Marizomib

• DrugTemozolomide

  Oral Administration of Temozolomide

  Also known as: TMZ

• Radiationradiotherapy

  60 Gy in 30 fractions over 6 weeks

  Also known as: RT

Primary outcomes

1. Overall Survival (OS)

   Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.

   Time frame: From the date of randomization up to the date of death, assessed up to 49 months

Secondary outcomes

1. Progression Free Survival (PFS)

   PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.

   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)

   HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.

   Time frame: From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.

3. Mini Mental State Examination (MMSE)

   MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change.

   Time frame: From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.

Baseline characteristics

Study documents

• Study protocol · Jun 20, 2022
• Statistical analysis plan · Mar 18, 2021

Documents are hosted by the registry — open the source record to download them.