ACTRN12616000908437
招募中
未知
The Cancer Molecular Screening and Therapeutics (MoST) Program - A framework protocol for multiple, parallel, signal-seeking clinical studies of novel molecularly targeted therapies for patients with advanced cancer and unmet clinical need.
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Cancer
- 发起方
- niversity of Sydney
- 入组人数
- 7628
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Inclusion Criteria \- Molecular Screening
- •1\.Male or female patients, aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any histologic type or an earlier diagnosis of a poor prognosis cancer;
- •2\.Sufficient and accessible tissue for molecular screening;
- •3\.Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (where standard therapy exists) or have documented unsuitability for any further standard anticancer therapy. Poor prognosis cancers or cancers with low expected response rate to standard treatment (in the opinion of the investigator and based on available evidence) may be screened on an earlier line of treatment.
- •a.Failure is defined as either progression of disease (clinical or radiological) or intolerance to standard therapy resulting in the discontinuation of the therapy.
- •b.Documented unsuitability for further standard therapy includes known hypersensitivity, organ dysfunction or other patient factors that would make therapy unsuitable in the judgement of the responsible investigator;
- •4\.ECOG performance status 0, 1 or 2;
- •5\.Willing and potentially able to comply with study requirements, including treatment, timing and/or nature of required assessments; It is the intention to screen patients who are in principle wishing to take part in a MoST substudy if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase;
- •6\.Signed, written informed consent to participation in the molecular screening
- •Inclusion Criteria \- Treatment sub\-study
排除标准
- •Exclusion criteria \- Molecular Screening
- •1\.Suitable for standard therapy or accepted standard care, if the patient has not been previously treated;
- •2\.Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may contraindicate participation and/or interact with the investigational product(s);
- •3\.Other co\-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
- •4\. For non central nervous system (CNS) cancers, patients with symptomatic CNS involvement of his/her cancer. Subjects with stable neurological function ,on stable doses of steroids/anti\-epileptics over 4 weeks, and with no evidence of CNS progression within 12 weeks prior to study entry are eligible;
- •5\.History of another malignancy within 2 years prior to registration unless adequately treated and determined free of progressive and metastatic disease for at least 6 months. Patients with a past history of adequately treated carcinoma\-in\-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible;
- •6\.Pregnancy, lactation, or inadequate contraception. Women must be post\-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a barrier method of contraception (double barrier, if required).
- •Exclusion criteria \- Treatment Sub\-study
- •Exclusion criteria will include those relevant for screening but also include:
- •1\.Contraindications to investigational product, as listed in the substudy addendum and outlined in the Investigator Brochure appended to each substudy module;
结局指标
主要结局
未指定
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