NCT04227522

Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MAMOC is a multicenter, randomized, placebo controlled, double blind study including BRCA negative patients with histologically confirmed, advanced (FIGO stage IIIA, IIIB, IIIC, or IV of the 2014 FIGO classification) high grade serous or high grade endometrioid (based on local histopathological findings) ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary in first line therapy.

Detailed description

The main scope of this trial is to determine progression free survival in BRCA negative patients treated with Rucaparib as maintenance therapy vs. Placebo after receiving Bevacizumab for 12 to 15 months. BRCA negative patients will be stratified according to time point of surgery (adjuvant vs. neoadjuvant), result of surgery (tumor free vs. not tumor free resection), study site and response (complete response (CR) vs. partial response (PR)/SD) and randomized 2:1 to receive either Rucaparib (Arm A) or Placebo (Arm B). In both of the arms, tumor assessments (CT or MRI) are performed before randomization, and every 6 months thereafter. During treatment, clinical visits (blood cell counts, detection of toxicity) occur every 4 weeks. Physical examinations will take place every 12 weeks. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs). About 30 sites in Germany will participate in this study to recruit 190 BRCA negative patientsin 24 months.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer
• Clear Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Rucaparib	A starting dose of 600 mg Rucaparib is taken twice daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
DRUG	Placebos	Placebo is taken daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.

Timeline

• Start date: 2020-06-08
• Primary completion: 2023-12-01
• Completion: 2024-07-01
• First posted: 2020-01-13
• Last updated: 2024-11-15

Locations

17 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study