A randomized, open-label, active-controlled, Phase II study of intravenous anetumab ravtansine (BAY 94-9343) or vinorelbine in patients with advanced or metastatic malignant pleural mesothelioma overexpressing mesothelin and progressed on first line platinum/pemetrexed-based chemotherapy - Mesothelioma.

Bayer0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin
•2. Unresectable locally advanced or metastatic MPM after a locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed.
•3. Patients must have measurable disease
•4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
•5. Life expectancy of at least 3 months
•6. Adequate bone marrow, liver- and renal function
•7. Left ventricular ejection fraction (LVEF) * 50% of the lower limit of normal (LLN) according to local institution ranges of normality.

•1. More than 1 previous systemic anti-cancer therapy line
•2. Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the ophtalmologist
•3. Symptomatic brain metastases or meningeal tumors or other uncontrolled metastases in the central nervous system (CNS).
•4. Evidence of history of bleeding diasthesis.
•5. Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute*s Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade > 2.
•6. Pre-existing cardiac conditions

发起方