NL-OMON39828已完成不适用
An open label phase I dose finding study of BI 853520 administered orally in a continuous dosing schedule in patients with various advanced or metastatic non-hematologic malignancies - BI 853520 in solid tumours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
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
- •- Patients with a confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging;
- •- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options;
- •-Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy);
- •- Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2);
- •- Age >= 18 years;
- •- Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation;
- •- Eastern Cooperative Oncology Group (ECOG), performance score 0-1;
- •Additional inclusion criteria in the expansion phase:
- •- Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
- •- Patients must be willing to provide paired tumour biopsies for PD determination. Refer to section 5.6.3;
- •- Patients should fit into one of the categories described below:;
- •I. Metastatic adenocarcinoma of the pancreas;
- •Patients should have preferably received at least one line of systemic treatment for metastatic disease and preferably not more than 2 prior regimens for metastatic disease.;
- •II. Platinum-resistant ovarian carcinoma, defined as recurrence within 6 months after completion of prior platinum-based chemotherapy;
- •Patients should have preferably received no more than 5 previous lines of systemic treatment for metastatic disease;
- •III. Oesophageal carcinoma;
- •Patients with oesophageal carcinoma of adenocarcinoma- or squamous cell histology who have received preferably not more than 2 previous lines of systemic treatment for metastatic disease;
- •IV. Soft tissue sarcoma;
- •Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease.;
排除标准
- •- Serious concomitant non-oncological disease/illness;- Pregnancy or breastfeeding;- Active/symptomatic brain metastases;- Second malignancy;- Women or men who are sexually active and unwilling to use a medically acceptable method of contraception ;- Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication
研究者
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