ACTRN12617001000392已完成2 期
Single arm, open label, signal seeking, phase IIa trial of the activity of Olaparib in combination with Durvalumab in patients with tumours with homologous recombination repair defects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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. Patients with tumours carrying the following:
- •Germline or somatic deleterious germline or somatic mutations/deletions in BRCA1 or BRCA 2
- •Germline or somatic mutations/deletions in non-BRCA1/2 HR pathway genes including ATM, PALB2, RAD51C, RAD51D, CHEK1, CHEK2, ATR, CDK12, BAP1, BARD1, BRIP1 and FANC genes.
- •3. Sufficient and accessible tissue for PDL-1 testing and for exploratory objectives;
- •4. Received and failed all standard anticancer therapy (where standard therapy exists) or have documented unsuitability for any further standard anticancer therapy – with the exception of current therapy patient is receiving. It is the intention to screen patients whilst they are receiving the last line of planned standard therapy.
- •5. ECOG performance status 0 or 1;
- •6. Willing and potentially able to comply with study requirements, including treatment, timing and/or nature of required assessments;
- •7. Adequate organ function
- •These are some of the inclusion criteria. You will be assessed for all criteria when joining the study.
排除标准
- •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 comorbidities 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, unless the subject has stable neurological function without evidence of CNS progression within 12 weeks prior to study entry and does not require treatment with enzyme-inducing anticonvulsants or steroids (within 4 weeks prior to substudy inclusion and during substudy participation);
- •5. Administration of any non-oncologic investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment;
- •6. History of another malignancy within 2 years prior to registration. 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;
- •7. 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).
- •8. Patients with BRCA1 or BRCA2 mutant breast, ovarian or prostate cancer
- •9. Patients who are eligible for other clinical studies involving durvalumab and/or olaparib
- •10. Blood transfusions within 28 days prior to registration
- •11. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab and/or a PARPi, including olaparib
- •12. Mean QT interval corrected for heart rate (QTc) greater than or equal to 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s Correction
- •13. Current or prior use of immunosuppressive medication within 7 days before the registration, including corticosteroids (greater than 10 mg/day of intranasal and inhaled prednisolone or equivalent systemic corticosteroids at physiological doses)
- •14. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). Subjects without active disease in the last 5 years may be included at discretion of the Investigator. Subjects with the following conditions are eligible: vitiligo, alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy, celiac disease controlled by diet alone.
- •15. Current or prior use of immunosuppressive medication within 7 days before the registration, including corticosteroids (greater than 10 mg/day of intranasal and inhaled prednisolone or equivalent systemic corticosteroids at physiological doses)
- •16. History of primary immunodeficiency or allogeneic organ transplantation
- •17. History of leptomeningeal carcinomatosis
研究者
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