Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)
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|ClinicalTrials.gov Identifier: NCT04915404|
Recruitment Status : Not yet recruiting
First Posted : June 7, 2021
Last Update Posted : June 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma Multiforme||Drug: Berubicin Hydrochloride||Phase 1 Phase 2|
The planned minimum duration of the study for an individual patient is approximately 11 weeks as follows:
- A 4-week Screening Period
- A 3-week Treatment Period (ie, one 3 week treatment cycle)
- A 4-week End-of-Treatment follow-up Period after the last dose The 3-week treatment cycles may be repeated in the absence of clinical and/or neurological deterioration, or unacceptable toxicity, and as long as both the patient and investigator agree that further therapy is in the patient's best interest.
After the End-of-Treatment follow-up visit, patients will enter a Post-Study follow-Up Period of up to approximately 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy|
|Estimated Study Start Date :||July 15, 2021|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||January 31, 2025|
Experimental: pK Assessment of Berubicin and its active metabolite
The first 18 patients will undergo a pK assessment of Berubicin and it's active metabolite Berubicinol during the dosing days of the first two cycles. After 18 patients are done n intern analysis will new performed.
Drug: Berubicin Hydrochloride
Berubicin intravenously infused will be administered at a dose of 7.1 mg/m2 as free base (equivalent to 7.5 mg/m2 Berubicin HCl) as a 2-hour intravenous (IV) infusion once daily for 3 consecutive days followed by 18 days off study drug (each cycle = 21 days).
- objective response rate (ORR) [ Time Frame: 6 months ]To confirm the efficacy (or futility) of Berubicin treatment on objective response rate (ORR) defined as CR or PR per modified Response Assessment in Neuro-Oncology (m RANO) criteria in patients with GBM (World Health Organization [WHO] Grade IV) that has recurred after standard initial therapy, based on Simon's 2-stage design
- • To confirm the safety profile of Berubicin that was characterized during Phase 1 studies and assess the effect of Berubicin on event-free survival (EFS) [ Time Frame: 6 months ]• To assess the effect of Berubicin on event-free survival (EFS) defined as the length of time from the initiation of study drug administration to stable disease , disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, intolerance, disease-related conditions, or failure to respond). Safety will be monitored by a safety review committee (SRC). The SRC will review PK and safety data from the first 2 cycles of treatment for the first approximately 18 patients (i.e., Stage 1) of this study
- • To confirm the pharmacokinetic (PK) profile of Berubicin and its metabolite, berubicinol, that was characterized during Phase 1 studies [ Time Frame: 6 months ]intensive pK assessment of Berubicin and it's active metabolite will be performed during the dosing days of the first two cycles , this will be folowed by an interim analysis at 18 patients time point.Plasma samples will be collected from the first approximately 18 patients enrolled, and concentrations of Berubicin and its metabolite, berubicinol, will be measured
- • To assess the effect of Berubicin on disease control rate (DCR) defined as CR or PR or stable disease [SD] per m-RANO criteria in patients with GBM after failure of standard first line therapy [ Time Frame: 12 months ]Screening/baseline MRI scans will be evaluated by a central reader for validation of eligibility and documentation of initial measurements. During the Treatment Period, the baseline scan will be compared with scans at 6-week (2-cycle) intervals for evaluation of disease by the investigator as well as the central reader according to m-RANO criteria.