PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer
Recruiting
Phase 2Phase 3Interventional Study
Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
N.N. Alexandrov National Cancer Centre · Government
Who this trial is looking for
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This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18-≤75 years.
* Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Possibility of performing diagnostic lap…
Inclusion Criteria:
* Age ≥18-≤75 years.
* Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Possibility of performing diagnostic laparoscopy or cytoreductive surgery.
* Presence of homologous recombination deficiency (HRD).
* No contraindications to chemotherapy, or bevacizumab.
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Presence of another active malignant invasive neoplasm.
* Pregnancy or lactation period.
* Disease progression during treatment.
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