NL-OMON47688已完成2 期
A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium - NiCCC Trial
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Patients will be eligible for the study if the following criteria
- •1. Progressive or recurrent ovarian peritoneal or fallopian tube clear
- •cell carcinoma, or progressive or recurrent endometrial clear cell
- •carcinoma. The primary diagnosis must be histologically confirmed
- •and central pathological review of the presenting tumour or biopsy
- •of relapsed disease must find at least 50% clear cell carcinoma
- •with no serous differentiation. Progressive disease as defined by
- •RECIST 1.1
- •2. Failure after >=1 prior platinum containing regimen which may have
- •been given in the adjuvant setting. For patients with ovarian clear
- •cell carcinoma, progression must have occurred within 6 calendar
- •months of their last platinum dose.
- •3. ECOG Performance status of <=2
- •4. Life expectancy of >3 months
- •5. Adequate hepatic, bone marrow coagulation and renal function
- •a. Hepatic function: total bilirubin< ULN; ALT and AST < 2.5 x
- •b. Coagulation parameters: INR <2 x ULN and prothrombin
- •time and activated partial thromboplastin time < 1.5 x ULN
- •in the absence of therapeutic anticoagulation
- •c. Absolute neutrophil count (ANC) >=1.5 x 109/L
- •d. Platelets >= 100 x 109L
- •e. Haemoglobin >= 9.0 g/dL
- •f. Proteinuria < grade 2 (CTCAE version 4)
- •NiCCC ISRCTN50772895
- •Version 3, 29th March 2016 Page 6 of 88
- •g. Glomerular Filtration Rate >=40ml/min. (calculated using
- •the Wright, Cockroft & Gault equation or measured by EDTA
- •6. Female and > 18 years of age
- •7. Signed and dated written informed consent prior to admission to
- •the study in accordance with ICH-GCP guidelines and local
- •legislation.
- •8. Willingness and ability to comply with scheduled visits, treatment
- •plans and laboratory tests and other study procedures.
排除标准
- •Patients will be excluded from the study in the following
- •circumstances:
- •1. Prior treatment with Nintedanib or other angiogenesis
- •inhibitor/VEGF targeted therapy, except for prior
- •treatment with bevacizumab which is permitted.
- •2. Treatment within 28 days prior to randomisation with any
- •investigational drug, radiotherapy, immunotherapy,
- •chemotherapy, hormonal therapy or biological therapy.
- •Palliative radiotherapy may be permitted for symptomatic
- •control of pain from bone metastases in extremities,
- •provided that the radiotherapy does not affect target
- •lesions, and the reason for the radiotherapy does not
- •reflect progressive disease.
- •3. Previous treatment with the chemotherapy regimen
- •selected as the control arm by the investigator. (Prior
- •therapy with paclitaxel given on a three weekly regimen is
- •permitted for patients receiving weekly Paclitaxel. Prior
- •treatment with weekly paclitaxel is permitted where this
- •has been used as part of first line therapy and it is greater
- •than 6 months since the last dose of weekly paclitaxel.
- •Prior weekly paclitaxel for relapsed disease is not
- •permitted).
- •4. Other malignancy diagnosed within 5 years of enrolment
- •except for:
- •a. Non-melanomatous skin cancer (if adequately treated)
- •b. Cervical carcinoma in situ (if adequately treated)
- •c. Carcinoma in situ of the breast (if adequately treated)
- •d. For patients with ovarian clear cell cancer, prior or
- •synchronous endometrial cancer (if adequately treated),
- •provided all of the following criteria are met:
- •Disease stage FIGO Stage 1a (tumour invades less than
- •one half of myometrium)
- •Grade 1 or 2
- •5. Patients with any other severe concurrent disease, which
- •may increase the risk associated with study participation
- •or study drug administration and, in the judgement of the
- •investigator, would make the patient inappropriate for
- •entry into this study, including significant neurologic,
- •psychiatric, infectious, hepatic, renal, or gastrointestinal
- •diseases or laboratory abnormality.
- •6. Symptoms or signs of gastrointestinal obstruction
- •requiring parenteral nutrition or hydration or any other
- •gastro-intestinal disorders or abnormalities, including
- •difficulty swallowing, that would interfere with drug
- •absorption.
- •7. Serious infections in particular if requiring systemic
- •NiCCC ISRCTN50772895
- •Version 3, 29th March 2016 Page 7 of 88
- •antibiotic (antimicrobial, antifungal) or antiviral therapy,
- •including known hepatitis B and/or C infection and HIVinfection.
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