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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18-≤75 years. - diagnosed by tissue sample (biopsy-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 willing to sign a consent form to participate in the study. Who Should NOT Join This Trial: - Presence of another active malignant invasive neoplasm. - Pregnancy or lactation period. - Disease progression during treatment. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

PARP inhibitor + Bevacizumab

Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel + bevacizumab (≥3 cycles) every 21 days. In case of a complete or partial response maintenance therapy is carried out until disease progression or intolerable toxicity or for 2 years to the regimen of PARP inhibitor + bevacizumab.

DRUG

PARP inhibitor

Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel every 21 days. In case of a complete or partial response maintenance therapy of PARP inhibitor is carried out until disease progression or intolerable toxicity or for 2 years.

Locations (1)

N.N. Alexandrov National Caner Centre
Minsk, Lesnoy, Belarus