EUCTR2009-016846-16-GB进行中（未招募）1 期
Phase II Clinical Trial of 6-Mercaptopurine(6MP)and low-dose Methotrexate In Patients With Known BRCA Defective Tumours. - A Phase II Clinical Trial in Patients with BRCA defective Tumours
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 67
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
入选标准
- •1.Patients with proven BRCA1 or BRCA2 mutations and after appropriate exposure to standard treatment, as defined by:
- •Breast Cancer
- •a) Patients with initially histologically or cytologically proven locally advanced or metastatic breast cancer who may have received up to 3 previous lines of chemotherapy in the locally advanced or metastatic breast cancer setting.
- •b) Patients must have previously had a taxane and an anthracycline in either the adjuvant or metastatic setting, provided that these were not contraindicated(by patient toxicities or patient refusal).
- •c) Patients with hormone responsive disease should have had at least 1 line of hormone therapy for metastatic disease unless contraindicated (by expected toxicities or patient refusal).
- •d) Prior treatment with a PARP inhibitor is permissible.
- •Ovarian/ Fallopian tube/ Primary Serous Peritoneal Cancer
- •a) Patients with initially histologically or cytologically proven ovarian, fallopian tube or primary serous peritoneal cancer.
- •b) Patients must have disease that is platinum resistant or in whom further platinum based therapy is inappropriate.
- •c) Prior treatment with a PARP inhibitor is permissible.
- •2. Patients must have measurable disease as defined by RECIST v1.1 criteria;
- •3.Age =18 years
- •4.ECOG performance score of 0-2
- •5.Life expectancy of >12 weeks
- •6.Adequate haematological and biochemical function.
- •7.Written informed consent
- •8.No prior anti-cancer treatment in previous 4 weeks, other than palliative RT.
- •9. Haematological and biochemical indices within the ranges given at screening and on cycle 1 day 1.
- •10. Ascites and pleural effusions must be drained prior to therapy
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients with any of the following contra-indications to thiopurines (6MP/ 6TG) or methotrexate:
- •family history of severe liver failure;
- •porphyria;
- •diffuse infiltrative pulmonary or pericardial disease;
- •known hypersensitivity to either trial agent.
- •2. Patients found to have a Low/Low genotype on TPMT testing will be excluded.
- •3. Pregnant or breast-feeding women
- •4. Any other active malignancy requiring treatment/ or whose prognosis will prevent readout from trial endpoints.
- •5. Patients known or tested to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- •6. Patients with active CNS lesions are excluded (i.e., those with radiographically
- •unstable, symptomatic lesions). However, patients treated with stereotactic
- •therapy or surgery and/or whole brain radiotherapy are eligible if the patient
- •remains without evidence of disease progression in brain = 3 months prior to registration date. They must also be off corticosteroid therapy for = 3 weeks prior to registration date.
- •7. Patients who have received anticancer agent(s) or an investigational agent within 28 days prior to study drug administration.
- •8. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
研究者
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