Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients (MAMOC)
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|ClinicalTrials.gov Identifier: NCT04227522|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Clear Cell Carcinoma||Drug: Rucaparib Drug: Placebos||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients|
|Actual Study Start Date :||June 8, 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2025|
Experimental: Arm A (Rucaparib)
Rucaparib treatment (starting dose 600 mg, twice daily) after receiving Bevacizumab for 12 to 15 months. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.
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.
Placebo Comparator: Arm B (Placebo)
Placebo treatment after receiving Bevacizumab for 12 to 15 months. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.
Placebo is taken daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
- Progression free survival (PFS) [ Time Frame: 48 months ]time from randomization until disease progression or death
- Progression free survival 2 (PFS2) [ Time Frame: 48 months ]time from randomization to second progression or death
- Quality of Life (QoL) 1 [ Time Frame: 48 months ]Patients are asked to answer the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). Responses of questions 1-28 are based on a 4-point scale (1=not at all; 4=Very much), with a higher score indicating a high degree of symptomatology and must therefore be assessed negatively. Responses of questions 29 and 30 are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status.
- Quality of Life 2 [ Time Frame: 48 months ]Patients are asked to answer the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28). Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better symptoms.
- Quality of Life/ Global health status 3 [ Time Frame: 48 months ]Patients are asked to answer the short version of the SF-36 Health Survey (SF-12). The questionnaire contains a total of 12 questions with different response options. For questions 1, 8 and 12 there are 5 (1=excellent, 5=bad), for question 2-3 there are 3 (1=yes, very restricted, 3=no, not restricted at all) and for questions 9-11 there are 6 response options (1= always, 6 = never). Questions 4-7 can be answered with "Yes" or "No".
- Quality of Life 4 [ Time Frame: 48 months ]Patients are asked to answer the questionnaire Fatigue Symptom Inventory (FSI). Responses are based on a 10 point grading scale (0=not at all tired/ exhausted; 10=completely tired/ exhausted), with a lower score indicating a lower symptomatology of fatigue.
- Quality of Life 5 [ Time Frame: 48 months ]Patients are asked to answer the Everyday Memory Questionnaire. Responses are based on a 5-point scale (1=occasionally; 5=very often), with a lower score indicating a better performance on memory associated Everyday activities.
- Quality of Life 6 [ Time Frame: 48 months ]Patients are asked to answer a custom form of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events developed by the National Cancer Institute (NCI PRO-CTCAE™) Version 1.0. The frequency and strength of symptoms is queried. There are 5 possible answers: "not at all", "a little", "moderate", "quite", "very".
- Determination of time to next medical intervention [ Time Frame: 48 months ](e.g. bowel obstruction, Ascites puncture)
- Time to next subsequent therapy [ Time Frame: 48 months ]e.g. chemotherapy
- Number of participants with treatment-related adverse events and/or serious adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 months ]AEs/SAEs
- Overall survival (OS) [ Time Frame: 72 months ]defined as time from Randomization to death by any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227522
|Contact: Maren Keller, Dr.||+4930403 68 65 firstname.lastname@example.org|
|Contact: Jessica Dysarz||+4930403 68 65 email@example.com|
|Principal Investigator:||Jalid Sehouli, Prof. Dr.||Charité-Universitätsmedizin Berlin Campus Virchow-Klinikum|