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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Status
Active
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Rucaparib
Placebos
Sponsored by
North Eastern German Society of Gynaecological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Rucaparib, maintenance therapy, Bevacizumab, Ovarian Cancer, BRCA negative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  2. Age ≥ 18.
  3. 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.
  4. Availability of archival tumor tissue for central next-generation sequencing (NGS) Analysis and no Detection BRCA mutation (BRCAnegative).
  5. Treatment with Bevacizumab or respective biosimilar for 12 to 15 months, independent of dosage.
  6. Patients who have completed first line platinum-taxane chemotherapy and at least stable disease after treatment with Bevacizumab before randomization.
  7. Patients must be randomized at least 3 weeks and no more than 9 weeks after their last dose of Bevacizumab (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTCAE grade 1 or better (except alopecia and peripheral neuropathy).
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  9. Patients must have normal organ and bone marrow function:

    1. Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to Screening hemoglobin assessment
    2. Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L
    3. Platelet count ≥ 100 x 109 /L
    4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
    5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤3 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN
    6. Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance > 30 mL/min
    7. Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN.
  10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test result ≤3 days prior to administration of the first dose of rucaparib.

Patients are considered to be of childbearing potential unless 1 of the following applies:

  1. Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or
  2. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 milli International Units/milliliter (mIU/mL) or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state.

Female patients of reproductive potential must practice highly effective methods (failure rate < 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of rucaparib or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (eg, calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate.

Exclusion Criteria:

  1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors) and Ovarian tumors of low malignant potential (e.g. borderline tumors), or low grade serous ovarian cancer, or low grade endometrioid ovarian cancer, or mucinous carcinoma.
  2. Patients with myelodysplastic syndrome/acute myeloid leukemia history.
  3. Patients receiving radiotherapy within 6 weeks prior to study treatment.
  4. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  5. Previous allogeneic bone marrow transplant.
  6. Use of any other PARP-inhibitor in first line therapy.
  7. Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
  8. Clinically significant (e.g. active) cardiovascular disease.
  9. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
  10. History or evidence of hemorrhagic disorders within 6 months prior to randomization.
  11. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
  12. History or evidence for brain metastases or spinal cord compression.
  13. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
  14. Significant traumatic injury during 4 weeks prior to randomization.
  15. Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations.
  16. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
  17. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
  18. Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria).
  19. Participation in another clinical study with an investigational product immediately prior to randomization.
  20. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  21. Patients with a known hypersensitivity to Rucaparib or any of the recipients of the product.
  22. Known human immunodeficiency virus (HIV) or acquired immunodeficiency Syndrome (AIDS)-related illness, or history of chronic hepatitis B or C.
  23. Other active malignancy requiring treatment.
  24. Patient who might be dependent on the sponsor, Clinical Research Organization (CRO), site or the investigator.
  25. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 Arzneimittelgesetz (AMG).

Sites / Locations

  • Universitätsklinikum Aachen
  • ANregiomed Frauenklinik Ansbach
  • Helios Klinikum Berlin-Buch
  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Universitätsklinikum Bonn
  • Klinikum Chemnitz gGmbH
  • Städtisches Klinikum Dessau
  • Universitätsklinikum Carl Gustav Carus
  • Kliniken Essen Mitte
  • Krankenhaus St. Elisabeth & St. Barbara
  • Universitätsklinikum Hamburg-Eppendorf
  • Diakovere Henriettenstift Hannover
  • Universitätsklinikum Jena
  • ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken g AG
  • Städtisches Krankenhaus Kiel
  • ZAGO-Zentrum für ambulante gynäkologische Onkologie
  • Uniklinikum Leipzig
  • Universitätsklinikum Mannheim
  • LMU Klinikum Großhadern
  • Universitätsklinikum Münster
  • Sana Klinikum Offenbach
  • Studienzentrum Onkologie Ravensburg
  • CaritasKlinikum Saarbrücken
  • Helios Dr. Horst Schmidt Kliniken Wiesbaden
  • Helios Universitätsklinikum Wuppertal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A (Rucaparib)

Arm B (Placebo)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
time from randomization until disease progression or death

Secondary Outcome Measures

Progression free survival 2 (PFS2)
time from randomization to second progression or death
Quality of Life (QoL) 1
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
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
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
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
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
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
(e.g. bowel obstruction, Ascites puncture)
Time to next subsequent therapy
e.g. chemotherapy
Number of participants with treatment-related adverse events and/or serious adverse events as assessed by CTCAE v4.03
AEs/SAEs
Overall survival (OS)
defined as time from Randomization to death by any cause

Full Information

First Posted
December 20, 2019
Last Updated
March 28, 2023
Sponsor
North Eastern German Society of Gynaecological Oncology
Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Clovis Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04227522
Brief Title
Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients
Acronym
MAMOC
Official Title
Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Eastern German Society of Gynaecological Oncology
Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Clovis Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Clear Cell Carcinoma
Keywords
Rucaparib, maintenance therapy, Bevacizumab, Ovarian Cancer, BRCA negative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Rucaparib)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (Placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo is taken daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
time from randomization until disease progression or death
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Progression free survival 2 (PFS2)
Description
time from randomization to second progression or death
Time Frame
48 months
Title
Quality of Life (QoL) 1
Description
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.
Time Frame
48 months
Title
Quality of Life 2
Description
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.
Time Frame
48 months
Title
Quality of Life/ Global health status 3
Description
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".
Time Frame
48 months
Title
Quality of Life 4
Description
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.
Time Frame
48 months
Title
Quality of Life 5
Description
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.
Time Frame
48 months
Title
Quality of Life 6
Description
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".
Time Frame
48 months
Title
Determination of time to next medical intervention
Description
(e.g. bowel obstruction, Ascites puncture)
Time Frame
48 months
Title
Time to next subsequent therapy
Description
e.g. chemotherapy
Time Frame
48 months
Title
Number of participants with treatment-related adverse events and/or serious adverse events as assessed by CTCAE v4.03
Description
AEs/SAEs
Time Frame
48 months
Title
Overall survival (OS)
Description
defined as time from Randomization to death by any cause
Time Frame
72 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Age ≥ 18. 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. Availability of archival tumor tissue for central next-generation sequencing (NGS) Analysis and no Detection BRCA mutation (BRCAnegative). Treatment with Bevacizumab or respective biosimilar for 12 to 15 months, independent of dosage. Patients who have completed first line platinum-taxane chemotherapy and at least stable disease after treatment with Bevacizumab before randomization. Patients must be randomized at least 3 weeks and no more than 9 weeks after their last dose of Bevacizumab (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTCAE grade 1 or better (except alopecia and peripheral neuropathy). Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Patients must have normal organ and bone marrow function: Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to Screening hemoglobin assessment Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L Platelet count ≥ 100 x 109 /L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤3 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance > 30 mL/min Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test result ≤3 days prior to administration of the first dose of rucaparib. Patients are considered to be of childbearing potential unless 1 of the following applies: Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 milli International Units/milliliter (mIU/mL) or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state. Female patients of reproductive potential must practice highly effective methods (failure rate < 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of rucaparib or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (eg, calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate. Exclusion Criteria: Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors) and Ovarian tumors of low malignant potential (e.g. borderline tumors), or low grade serous ovarian cancer, or low grade endometrioid ovarian cancer, or mucinous carcinoma. Patients with myelodysplastic syndrome/acute myeloid leukemia history. Patients receiving radiotherapy within 6 weeks prior to study treatment. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Previous allogeneic bone marrow transplant. Use of any other PARP-inhibitor in first line therapy. Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics). Clinically significant (e.g. active) cardiovascular disease. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization. History or evidence of hemorrhagic disorders within 6 months prior to randomization. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation). History or evidence for brain metastases or spinal cord compression. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures). Significant traumatic injury during 4 weeks prior to randomization. Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications. Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria). Participation in another clinical study with an investigational product immediately prior to randomization. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. Patients with a known hypersensitivity to Rucaparib or any of the recipients of the product. Known human immunodeficiency virus (HIV) or acquired immunodeficiency Syndrome (AIDS)-related illness, or history of chronic hepatitis B or C. Other active malignancy requiring treatment. Patient who might be dependent on the sponsor, Clinical Research Organization (CRO), site or the investigator. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 Arzneimittelgesetz (AMG).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jalid Sehouli, Prof. Dr.
Organizational Affiliation
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
ANregiomed Frauenklinik Ansbach
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Städtisches Klinikum Dessau
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Kliniken Essen Mitte
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Krankenhaus St. Elisabeth & St. Barbara
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Diakovere Henriettenstift Hannover
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken g AG
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Facility Name
Städtisches Krankenhaus Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
ZAGO-Zentrum für ambulante gynäkologische Onkologie
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Uniklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
LMU Klinikum Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Sana Klinikum Offenbach
City
Offenbach
Country
Germany
Facility Name
Studienzentrum Onkologie Ravensburg
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
CaritasKlinikum Saarbrücken
City
Saarbrücken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Helios Dr. Horst Schmidt Kliniken Wiesbaden
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Helios Universitätsklinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Scienctists may submit a request for scientific use of the data after the first publication. This request shall be examined by the working group. After signing an agreement, the anonymous data can be made available to the scientist (password protected).
IPD Sharing Time Frame
after first main publication

Learn more about this trial

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

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