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A multi-centre, four-arm, randomised, double-blind study assessing the dose equivalence of bevacizumab in first-line therapy for ovarian cancer

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509659-15-00
Acronym
2023/ABM/01/00015
Enrollment
332
Registered
2024-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

fallopian tube cancer, Patients with ovarian cancer, peritoneal carcinoma

Brief summary

Objective Response Rate (ORR) to treatment, defined as the proportion of patients with a complete or partial response to treatment according to response evaluation criteria in solid tumors (RECIST v.1.1) within 4 weeks after the completion of the adjuvant treatment phase., Progression-free survival (PFS), defined as the time from randomization to disease progression/recurrence according to response evaluation criteria in solid tumors (RECIST v.1.1) or all-cause death, whichever comes first.

Detailed description

Frequency of adverse events (AE)., Frequency of serious adverse events (SAE)., Frequency of adverse events of special interest (AESI)., Death from any cause, ORR based on best overall response (BOR) over the entire treatment period according to RECIST v.1.1, Time from start of first-line chemotherapy to start of first subsequent therapy (TFST), An analysis of the study participant's quality of life will be made on the basis of: - the standardised quality of life questionnaires QLQ-C30 and QLQ-OV28 of the European Organisation for Research and Treatment of Cancer

Interventions

DRUGOLAPARIB
DRUGCARBOPLATIN
DRUGBEVACIZUMAB
DRUGPACLITAXEL

Sponsors

Uniwersytet Medyczny W Lublinie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR) to treatment, defined as the proportion of patients with a complete or partial response to treatment according to response evaluation criteria in solid tumors (RECIST v.1.1) within 4 weeks after the completion of the adjuvant treatment phase., Progression-free survival (PFS), defined as the time from randomization to disease progression/recurrence according to response evaluation criteria in solid tumors (RECIST v.1.1) or all-cause death, whichever comes first.

Secondary

MeasureTime frame
Frequency of adverse events (AE)., Frequency of serious adverse events (SAE)., Frequency of adverse events of special interest (AESI)., Death from any cause, ORR based on best overall response (BOR) over the entire treatment period according to RECIST v.1.1, Time from start of first-line chemotherapy to start of first subsequent therapy (TFST), An analysis of the study participant's quality of life will be made on the basis of: - the standardised quality of life questionnaires QLQ-C30 and QLQ-OV28 of the European Organisation for Research and Treatment of Cancer

Countries

Poland

Outcome results

None listed

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