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A prospective randomized open-label phase II clinical study evaluating the efficacy and safety of zoledronic acid addition to standard therapy in patients with glioblastoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519446-67-00
Acronym
PSKUS-GB01
Enrollment
80
Registered
2025-02-28
Start date
2025-03-06
Completion date
Unknown
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Brief summary

Overall Survival (OS): Time from randomization to death from any cause., Progression-Free Survival (PFS): Time from randomization to disease progression (per RANO criteria) or death, whichever occurs first.

Detailed description

Objective Response Rate (ORR): Proportion of patients achieving a complete or partial response per RANO criteria., Duration of Response (DOR): Time from the initial response to disease progression or death in patients who respond to treatment., Safety and Tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and treatment-related discontinuations, assessed according to NCI CTCAE v5.0 criteria.

Interventions

Sponsors

Pauls Stradins Clinical University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS): Time from randomization to death from any cause., Progression-Free Survival (PFS): Time from randomization to disease progression (per RANO criteria) or death, whichever occurs first.

Secondary

MeasureTime frame
Objective Response Rate (ORR): Proportion of patients achieving a complete or partial response per RANO criteria., Duration of Response (DOR): Time from the initial response to disease progression or death in patients who respond to treatment., Safety and Tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and treatment-related discontinuations, assessed according to NCI CTCAE v5.0 criteria.

Countries

Latvia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026