Trials Sponsors Conditions Drugs Pricing

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

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 Outcomes (3)

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

Zometa 4 mg/100 ml solution for infusionType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this protocol
Participants (females and males) who are age ≥ 18 years at the time of signing Informed Consent Form

Sponsors & Collaborators

Pauls Stradins Clinical University Hospital
Type not reportedlead

Study Sites (1)

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Sigita Hasnere+37126667117 sigita.hasnere@stradini.lv

Central Study Contacts

Sigita Hasnere

+37167069318 sigita.hasnere@stradini.lv

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

November 24, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-519446-67-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 08:07:18 UTC

Documents

Protocol

You may not qualify if:

Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the final dose of zoledronic acid or temozolamide, or within the time period specified per local prescribing guidelines after the final dose of chemotherapy
Participants who have received treatment with bisphosphonates within 2 years prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the investigator not to be scientifically or medically compatible with this study
Participants who have any other active malignancy
Participants who have relapsed glioblastoma or previous other type of glioma who has transformed to glioblastoma
Participants who have a known clinically significant history of liver disease consistent with Child-Pugh Class C, including hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis, as defined: Active infection is defined as requiring treatment with antiviral therapy or presence of positive test results for hepatitis B (hepatitis B surface antigen and/or total hepatitis B core antibody [HBcAb]) or HCV antibody; Participants who test positive for HBcAb are eligible only if test results are also positive for hepatitis B surface antibody and polymerase chain reaction is negative for HBV DNA; Participants who are positive for HCV serology are eligible only if testing for HCV RNA is negative
Participants who have acute or chronic kidney failure and GFR less than 60 ml/min
Participants who have serious mouth and dental infections and may need a dental procedures (except dental filling) in near future
Participants who have level of calcium in blood less than 2 mmol/l
Participants who have a known allergy or hypersensitivity to any of the study drugs or any of their excipients
Participants who have had a serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection within 14 days prior to screening
Participants who have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
Participants who are unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations