EUCTR2019-000399-41-DE进行中（未招募）1 期
Rucaparib MAintenance after Bevacizumab Maintenance following Carboplatin based first line chemotherapy in Ovarian Cancer patients - MAMOC
OGGO e. V.0 个研究点目标入组 190 人开始时间: 2019年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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 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 NGS analysis and Patient must be BRCA negative based on these results
- •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 CTC AE 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:
- •a. Hemoglobin = 9.0 g/dL independent of transfusion = 14 days prior to screening hemoglobin assessment
- •b. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •c. Platelet count = 100 x 109/L
- •d. Total bilirubin = 1.5 x institutional upper limit of normal (ULN); < 2 × ULN if hyperbilirubinemia is due to Gilbert’s syndrome
- •e. 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
- •f. Serum creatinine = 1.5 x institutional ULN and creatinine clearance > 30 mL/min
- •g. 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 study treatment.
- •Patients are considered to be of childbearing potential unless 1 of the following applies:
- •a) Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or
- •b) 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 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 implantabl
排除标准
- •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.
- •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. use of any other PARP-Inhibitor in first line therapy
- •6. 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).
- •9.History or evidence of hemorrhagic disorders within 6 months prior to randomization.
- •10.Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
- •11.History or or evidence for brain metastases or spinal cord compression.
- •12.History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
- •13.Significant traumatic injury during 4 weeks prior to randomization.
- •14.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.
- •15.Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
- •16.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.
- •17.Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria).
- •18.Participation in another clinical study with an investigational product immediately prior to randomization.
- •19.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •20.Patients with a known hypersensitivity to Rucaparib or any of the recipients of the product.
- •21.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C.
- •22.Other active malignancy requiring treatment.
- •23.Patient who might be dependent on the sponsor, CRO, site or the investigator.
- •24.Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
研究者
相似试验
已完成
3 期
Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer PatientsFallopian Tube CancerPrimary Peritoneal CancerOvarian CancerClear Cell CarcinomaNCT04227522North Eastern German Society of Gynaecological Oncology42
终止
不适用
The experience of rucaparib in women with ovarian cancerOvarian cancerCancerISRCTN10125751HS Greater Glasgow and Clyde34
尚未招募
2 期
Maintenance bevacizumab plus erlotinib versus observation in advanced Billiary tract cancerCTRI/2020/03/023943Tata Memorial Hospital
进行中（未招募）
不适用
Maintenance treatment with capecitabine and bevacizumab versus observation after induction treatment with capecitabine, oxaliplatin, and bevacizumab as first-line treatment in patients with advanced colorectal carcinoma, a randomised phase III study (CAIRO3 study) - CAIRO3Advanced colorectal carcinomaEUCTR2006-006657-27-NLDutch Colorectal Cancer Group
进行中（未招募）
不适用
A Phase IIIb study of MabThera rituximab maintenance therapy in patients with follicular Non-Hodgkin s Lymphoma who have responded to induction therapy. - MAXIMAline or relapsed patients with Grade 1, 2 or 3a, CD20 , follicular non-Hodgkin s Lymphoma who respond to rituximab-containing induction therapy.MedDRA version: 6.1Level: HLTClassification code 10016895EUCTR2005-004977-12-ITROCHE500