KCT0003806尚未招募未知
Phase II study of Ceralasertib (AZD6738) in combination with durvalumab (MEDI4736), in patients with metastatic solid tumor as salvage treatment
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Provision of fully informed consent prior to any study specific procedures.
- •2. Patients must be = 18 years of age
- •3. Patient with ATM deficient or ATM proficient through IHC. ATM expression status will be assessed prospectively. Minimum numbers of each patient group (ATM proficient and deficient) will be required for analysis, therefore central prospective screening will be deployed to ensure this is achieved.
- •4. Body weight >30kg
- •5. Cohort A: Confirmed histological or cytological diagnosis of gastric adenocarcinoma (including GEJ) that is at an advanced stage and that has progressed following who have failed secondary chemotherapy treatments (confirmed by imaging)
- •6. Cohort B: Confirmed melanoma (metastatic) who has progressed to prior anti-PD(L)1 therapy (immediate prior regimen)
- •7. Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (modified RECIST) version 1.1 which is suitable for accurate repeated measurements.
- •8. Provision of tumor sample (from either a resection or biopsy) for ATM IHC and other exploratory biomarker
- •9. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •10. ECOG performance status 0-1 with no deterioration between screening and the first dose of study treatment
- •11. Patients must have a life expectancy = 3 months from proposed first dose date.
- •12. Patients must have had a washout period of 3 weeks for any prior therapy prior to the start ot study drug. The following intervals between the end of the prior treatment and first dose of study drug must be observed: = 4 weeks for radiotherapy (patients who receive palliative radiation for nontarget lesions need not have a 4 week washout period and can be enrolled immediately); patients may receive a stable dose of bisphosphonates or denusomab as long as these were started at least 4 weeks prior to treatment; = 4 weeks for major surgery; = 7 days for minor surgical procedures; = 14 days (or 5 half lives whoever is longest) for any investigational product.
- •13. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- •- Haemoglobin =9.0 g/dL (transfusion not permitted within 14 days of study medication)
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- INR =1.5 or evidence of impaired hepatic synthesis function
- •- Platelet count =100 x 109/L (transfusion not permitted within 14 days of study medication
- •- Total bilirubin = 1.5 x institutional upper limit of normal (ULN)
- •- AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be = 5x ULN
- •- Serum creatinine =1.5 x institutional ULN
- •- Glomerular filtration rate < 45 mL/min as assessed by standard methodology at the investigating centre
- •- Haematuria: +++ on microscopy or dipstick
- •14. Female patients of childbearing potential must have a negative pregnancy test (urine or serum), must not be breastfeeding and using adequate contraceptive measures.
- •Female patients must use a highly effective contraceptive measure from screening until 90 days after the last dose of drug. All methods of contraception (except for total abstinence) should be used in combination with the use of a condom by a male sexual partner for intercourse (see Restrictions below).
- •Female patients must have evidence of non-ch
排除标准
- •1.Diagnosis of ataxia telangiectasia.
- •2.Any previous treatment with ATR inhibitors, DNA -damage repair inhibitors
- •3.Any gastrointestinal condition that would preclude adequate abosrportion of AZD6738 including but not limited to inability to swallow oral medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- •4.Active or prior documented autoimmune or inflammatory disorders (including IBD[e.g. Chohn’s disease, ulcerative colitis or diverticulitis], SLE, sarcoidosis syndrome, tuberculosis, Wegener syndrome, myasthenia gravis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, history of primary immunodeficiency or HIV infection, known hepatitis B or hepatitis C infection, history of organ transplant that requires use of immunosuppressives, glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis within the past 2 years prior to the start of treatment. The following are exceptions to this criterion:
- •- Subjects with vitiligo or alopecia, hypothyroidism (eg, following Hashimoto syndrome)
- •stable on hormone replacement or psoriasis not requiring systemic treatment; patients
- •with coeliac disease controlled by diet alone and patients without active disease in the
- •last 5 years may be included after consultation with Chief Investigator.
- •5.Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Note: Subjects previously treated for CNS metastases that are asymptomatic, radiographically and neurologically stable for at least 4 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 4 weeks prior to the first dose of treatment are not excluded.
- •6.Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for =3 years.
- •7.Current or prior use of immunosuppressive medication within 4 weeks prior to the first dose of durvalumab, with the exceptions of intranasal, topical, and inhaled corticosteroids; systemic corticosteroids at physiologic doses not to exceed a dose > 10 mg prednisone / day or equivalent)
- •8.Patient was in receipt of any live attenuated vaccination within 30 days prior to study entry or within 30 days of receving study therapy.
- •9.Receiving or having received, concomitant medications, herbal supplements, and/or foods that significantly modulate P450 3A4 (CYP3A4) or Pgp activity (washout periods of 5 half-lives). Note these include common azole antifungals, macrolide antibioics and other medications.
- •10.Patient with any of the following cardiac criteria:
- •- Mean QT interval corrected for heart rate (QTc) = 470 ms calculated from 3 electrograms (ECGs) using Friderecia’s correction
- •- Any clinciallly important abnormalities in fhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block , third degree heart block, second degree heart block.
- •- Any factors that increae the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or concomitant medication known to prolong the QT interval
- •- Uncontrolled hypotension: systolic BP
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