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A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508194-89-00
Acronym
WO42178
Enrollment
57
Registered
2024-02-08
Start date
2021-08-30
Completion date
Unknown
Last updated
2026-01-06

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

Conditions

Persistent or Recurrent Rare Epithelial Ovarian Tumors

Brief summary

Confirmed ORR as determined by the investigator according to RECIST v1.1

Detailed description

1. DOR as determined by the investigator and IRC according to RECIST v1.1, 2. DCR as determined by the investigator and IRC according to RECIST v1.1, 3. PFS as determined by the investigator and IRC according to RECIST v1.1, 4. Overall survival, 5. Confirmed ORR, as determined by the IRC according to RECIST v1.1, 6. Six (6)-month PFS rate as determined by the investigator, 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

Interventions

DRUGCotellic
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGLynparza 150 mg film-coated tablets
DRUGCotellic 20 mg film-coated tablets
DRUGIpatasertib
DRUGINAVOLISIB
DRUGSindaxel 6 mg/ml concentrat pentru soluţie perfuzabilă
DRUGVerzenios 50 mg film-coated tablets
DRUGLynparza 100 mg film-coated tablets
DRUGKadcyla 160 mg powder for concentrate for solution for infusion.
DRUGLETRO-cell® 2
DRUG5 mg Filmtabletten
DRUGVerzenios 100 mg film-coated tablets
DRUGRO7197597
DRUGVerzenios 150 mg film-coated tablets
DRUGPaclitaxel 6 mg/ml Concentrate for Solution for Infusion
DRUGTecentriq 1
DRUG200 mg concentrate for solution for infusion
DRUGIBRANCE 125 mg film-coated tablets
DRUGIBRANCE 75 mg film-coated tablets
DRUGIBRANCE 100 mg film-coated tablets
DRUGPaclitaxel Actavis 6 mg/ml koncentrat till infusionsvätska
DRUGlösning
DRUGPACLITAXEL AHCL 6 mg/ml
DRUGsolution à diluer pour perfusion
DRUGEndoxan 50 mg dengtos tabletės

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Confirmed ORR as determined by the investigator according to RECIST v1.1—

Secondary

MeasureTime frame
1. DOR as determined by the investigator and IRC according to RECIST v1.1, 2. DCR as determined by the investigator and IRC according to RECIST v1.1, 3. PFS as determined by the investigator and IRC according to RECIST v1.1, 4. Overall survival, 5. Confirmed ORR, as determined by the IRC according to RECIST v1.1, 6. Six (6)-month PFS rate as determined by the investigator, 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)—

Countries

Czechia, France, Germany, Italy, Spain

Outcome results

None listed

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