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

Phase 2

Completed

Conditions: asbestos cancer
carcinoma of the mesothelium lining lungs
Mesothelioma
10027412
10035597

Registration Number: NL-OMON43748

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess whether the study drug anetumab ravtansine is more effective than<br /><br>treatment with vinorelbine in patients with stage IV, mesothelin<br /><br>overexpressing malignant pleural mesothelioma measured by evaluating the<br /><br>progression free survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are overall survival, patient-reported outcomes, other<br /><br>efficacy parameters and safety. Other endpoints are evaluating the<br /><br>pharmacokinetics and biomarkers.</p><br>