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Phase II study of dornase alpha and cisplatin in refractory germ cell cancer.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510135-10-00
Acronym
GCTSK-007
Enrollment
33
Registered
2025-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-05

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

Conditions

germ cell cancer

Brief summary

12-week progression-free survival (intent-to-treat population)

Detailed description

Overall response rate (ORR) by RECIST 1.1 and tumor markers (AFP, HCG, LDH), Progression-free survival, Overall survival, Toxicity, Frequency of grade III and IV adverse events, Association between clinical outcome and biomarkers (exploratory analysis)

Interventions

DRUGCISPLATIN
DRUGPulmozyme 2 500 U/2
DRUG5 ml roztok na rozprašovanie

Sponsors

Narodny Onkologicky Ustav
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
12-week progression-free survival (intent-to-treat population)—

Secondary

MeasureTime frame
Overall response rate (ORR) by RECIST 1.1 and tumor markers (AFP, HCG, LDH), Progression-free survival, Overall survival, Toxicity, Frequency of grade III and IV adverse events, Association between clinical outcome and biomarkers (exploratory analysis)—

Countries

Slovakia

Outcome results

None listed

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