Health Trials

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

ConditionsOvarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorN.N. Alexandrov National Cancer Centre

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of another active malignant invasive neoplasm.

Pregnancy or lactation period.

Disease progression during treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PARP inhibitor + Bevacizumab

    Drug

    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.

  • PARP inhibitor

    Drug

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: PARPi + BevExperimental treatment 1 intervention
Group B: PARPiExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival

Time from randomization to any sign or symptom of the cancer or death from the disease

Time frame
From enrollment through study completion, an average of 2 year
2

The frequency of adverse events

Time frame
From date of first immunotherapy dose through 60 months, or date of last patient contact

Secondary outcomes

1

Disease-free survival 2

Time from the first recurrence when patient remains free of cancer signs or symptoms to any sign or symptom of the cancer or death from the disease

Time frame
From the first recurrence through study completion, an average of 2 year
2

Time from Randomization to First Subsequent Therapy

Time from randomization to the initiation of the next (second-line) therapy, most often due to disease progression.

Time frame
From enrollment through study completion, an average of 2 year
3

The quality of life

Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scales range from 0 to 100; higher scores indicate better outcomes on functional and global health scales, but worse outcomes on symptom scales

Time frame
Through study completion, an average of 5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

N.N. Alexandrov National Cancer Centre

Lead sponsor

Source ClinicalTrials.gov
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