Advanced (stage III B-C-IV) ovarian, primary peritoneal and Fallopian tube cancer.
Conditions
Brief summary
Phase I: Maximum Tolerated Dose (MTD): defined as the maximum dose at which no limiting toxicities occurr (see belove the definition of limiting toxicities) to recommend for the Phase II randomized design of the trial, Phase II: Progression-free survival, defined as the time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first) in patients treated according to HRD status.
Detailed description
Phase I: Toxicity of the Rucaparib-Bevacizumab combination in terms of haematologic and non haematologic events. Toxicity will be evaluated according to U.S. NCI Common Toxicity Criteria version 5.0, Phase I: Pharmacokinetic parameter in patient receiving the combination of Rucaparib and Bevacizumab, Phase II: Overall survival defined as the time from the date of randomization to the date of death in patients treated accordinf to HRD status, Phase II: Progression-free survival 2 (PFS2) defined as time from randomisation to second objective disease progression or death in patients treated accordinf to HRD status, Phase II: To compare the time from randomization to first subsequent therapy or death (TFST) in patients treated according to HRD status, Phase II: Time to second subsequent therapy (TSST) defined as time from randomisation to the initiation of second subsequent therapy or death in patients treated according to HRD status, Phase II: Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression or by the modifications of CA 125 according to GCIG criteria, Phase II: Adverse Events and laboratory abnormalities evaluated according to CTCAE version 5.0, Phase II: Patient-reported outcome (PRO) of disease-related symptoms utilizing Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Euro-Quality of Life 5D (EQ-5D) tool
Interventions
DRUGBEVACIZUMAB
DRUGCARBOPLATIN
DRUGPACLITAXEL
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Maximum Tolerated Dose (MTD): defined as the maximum dose at which no limiting toxicities occurr (see belove the definition of limiting toxicities) to recommend for the Phase II randomized design of the trial, Phase II: Progression-free survival, defined as the time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first) in patients treated according to HRD status. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Toxicity of the Rucaparib-Bevacizumab combination in terms of haematologic and non haematologic events. Toxicity will be evaluated according to U.S. NCI Common Toxicity Criteria version 5.0, Phase I: Pharmacokinetic parameter in patient receiving the combination of Rucaparib and Bevacizumab, Phase II: Overall survival defined as the time from the date of randomization to the date of death in patients treated accordinf to HRD status, Phase II: Progression-free survival 2 (PFS2) defined as time from randomisation to second objective disease progression or death in patients treated accordinf to HRD status, Phase II: To compare the time from randomization to first subsequent therapy or death (TFST) in patients treated according to HRD status, Phase II: Time to second subsequent therapy (TSST) defined as time from randomisation to the initiation of second subsequent therapy or death in patients treated according to HRD status, Phase II: Best target lesion response, defined as best | — |
Countries
Italy
Outcome results
None listed