EUCTR2013-003469-32-GB进行中（未招募）1 期
A Single Arm Phase II trial of BMN 673 for inoperable, advanced endometrial cancer with retrospective PTEN, MSI and MRE11 analysis. - PANDA
niversity College London0 个研究点开始时间: 2014年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- Age = 18 years
- •- Histologically confirmed endometrial cancer. All histological subtypes except for carcinosarcoma are eligible
- •- Evidence of inoperable, advanced, recurrent or metastatic disease by imaging and/or histological criteria
- •- = 1 previous line of systemic cancer therapy for inoperable, advanced, recurrent or metastatic endometrial cancer. Chemotherapy in the adjuvant setting is not considered a prior line of therapy unless recurrence occurred during adjuvant treatment or within 6 months of the last treatment; first line treatment of advanced disease must include at least one cytotoxic agent to be considered as a line of therapy; prior hormonal treatment is not considered a line of therapy in any setting
- •- Written informed consent obtained prior to any screening procedures
- •- Patients must give consent for analysis of archived histological diagnostic tissue for immunohistochemistry (IHC). If archived tissue is not available or is of insufficient quantity or quality, the patient will have the option to undergo biopsy if feasible. If biopsy is not feasible or the patient does not give consent for biopsy when archived tissue is not available, the patient will not be eligible for the trial. The quality and quantity of archived tissue will be assessed by a suitably qualified individual, usually a histopathologist, at site to ensure adequate tissue sample available for testing for PTEN, MSI and MRE11
- •- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
- •- Life expectancy > 12 weeks
- •- Patient has at least one site of measurable disease (i.e. target lesion) per RECIST v1.1
- •- Evidence of non-childbearing status and must not be lactating OR must have postmenopausal status
- •- Adequate bone marrow and organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Prior treatment with a PARP inhibitor
- •- Progressive disease =3 months after platinum-based chemotherapy
- •- Active uncontrolled infection including known Hepatitis B, Hepatitis C or HIV
- •- Obstruction of the gastrointestinal tract or other reason preventing effective oral administration of medication
- •- Serious concomitant non-malignant disease, uncontrolled organ dysfunction or medical disorder considered by the Investigator to make the subject unsuitable for trial participation including any psychiatric disorder that prevents informed consent
- •- Significant active cardiovascular disease
- •- Symptomatic brain metastases
- •- Immunosuppressant therapy or considered to be otherwise immunocompromised
- •- Myelodysplastic syndrome/acute myeloid leukaemia
- •- Major surgery within 4 weeks of registration or ongoing clinically significant post-surgical complications
- •- Chemotherapy, radiotherapy (a single fraction of palliative radiotherapy is allowed provided that the site being treated is not subsequently used as a target lesion as per RECIST v1.1 for the purpose of assessing tumour response on trial), immunotherapy or other investigational therapy for cancer within 21 days of registration (42 days for nitrosoureas, mitomycin-C)
- •- Unresolved clinically significant toxicities from prior systemic therapy
- •- Known hypersensitivity to any of the agents or excipients to be administered
- •- Unwillingness or inability to comply with the trial protocol
- •- History of other malignancy within 3 years of registration, except for:
- •oCone-biopsied in situ carcinoma of the cervix uteri
- •oBasal or squamous cell carcinoma of the skin
研究者
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