NL-OMON45155招募中不适用
A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease has Progressed on an EGFR TKI - AZD9291 - study D5160C00012
Astra Zeneca0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female, aged at least 18 years.
- •Histological or cytological confirmation diagnosis of NSCLC.
- •Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, eg, gefitinib or erlotinib. In addition, other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
- •Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks.
- •Patients must have a life expectancy of >=12 weeks as estimated at the time of screening.;For all inclusion criteria, please see section 3.1 of the protocol.
排除标准
- •Previous enrolment and dosing in the present study. Patients who were enrolled, screened but not dosed (ie, withdrew from the study prior to dosing) may be re-enrolled and re-screened if in the opinion of the Investigator, the reason(s) for earlier withdrawal no longer applies.
- •Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- •Treatment with any of the following: Treatment with an EGFR TKI (eg, erlotinib or gefitinib) within 8 days or approximately 5x half-life, whichever is the longer, of the first dose of study treatment. * Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- •* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
- •* Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment.
- •* Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior). All patients in part B and continued access must avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer effects on CYP3A4.
- •Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for AEs (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- •7. Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
- •Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator*s opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- •Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- •* Absolute neutrophil count (ANC) <1.5 x 109/L.
- •* Platelet count <100 x 109/L.
- •* Haemoglobin <90 g/L.
- •* Alanine aminotransferase >2.5 x the institutional ULN if no demonstrable liver metastases or >5 x institutional ULN in the presence of liver metastases.
- •* Aspartate aminotransferase >2.5 x institutional ULN if no demonstrable liver metastases or >5 x institutional ULN in the presence of liver metastases.
- •* Total bilirubin >1.5 x institutional ULN if no liver metastases or >3 x institutional ULN in the presence of documented Gilbert*s Syndrome (unconjugated hyperbilirubinaemia) or liver metastases.
- •* Creatinine >1.5 x institutional ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft-Gault formula); confirmation of creatinine clearance is only
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