Phase II clinical trial of 6-mercaptopurine (6MP) and low-dose methotrexate in patients with known BRCA defective tumours

niversity of Oxford (UK)0 个研究点目标入组 67 人开始时间: 2011年5月6日最近更新: 2023年4月3日

适应症

试验速览

2014 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/25526776 protocol (added 10/04/2019)

•Patients with proven BRCA1 or BRCA2 mutations and after appropriate exposure to standard treatment, as defined by:
•1. Breast cancer
•1.1. 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
•1.2. Patients must have previously had a taxane and an anthracycline in either the adjuvant or metastatic setting, provided that these were not contraindicated
•1.3. Patients with hormone responsive disease should have had at least one line of hormone therapy for metastatic disease
•1.4. Prior treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor is permissible
•2. Ovarian cancer
•2.1. Patients with initially histologically or cytologically proven ovarian cancer
•2.2. Patients must have disease that is platinum resistant or in whom further platinum based therapy is inappropriate
•2.3. Prior treatment with a PARP inhibitor is permissible
•3. Patients must have measurable disease on computerised tomography (CT) or magnetic resonance imaging (MRI) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
•4. Age more than or equal to 18 years
•5. ECOG performance score of 0-2
•6. Life expectancy of > 12 weeks
•7. Adequate haematological and biochemical function
•8. Written informed consent; Target Gender: Female ; Lower Age Limit 18 years

•1. Patients with any of the following contra-indications to thiopurines (6MP/6TG) or methotrexate:
•1.1. Family history of severe liver failure
•1.2. Porphyria
•1.3. Diffuse infiltrative pulmonary or pericardial disease
•1.4. Known hypersensitivity to either trial agent
•2. Patients found to have a Low/Low genotype on Thiopurine S-methyl transferase (TPMT) testing
•3. Pregnant or breast-feeding women
•4. Other active malignancy, with the exception of adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
•5. Patients known or tested to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (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

发起方

niversity of Oxford (UK)