A phase II study of orally administered BEZ235 monotherapy in patients with metastatic or unresectable malignant PEComa

Phase 2

Completed

• Conditions: Perivascular epithelioid cell tumors (PEComa); soft tissue tumor; 10072990

• Registration Number: NL-OMON37195
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

Histologically confirmed diagnosis of malgnant PEComa (included epithelioid angiomyolipoma (AML) in adult patients
Unresectable/advanced and/ or metastatic and documented progressive measurable disease
Treated with 1 or 2 prior lines of treatment

Exclusion Criteria

Disease exclusions: Lymphangioleiomyomatosis (LAM) exclusively
Active uncontrolled or symptomatic CNS metastases, concurent malignancy or malignancy in last three years.
Concurrent severe and/or uncontrolled medical condition (for details see protocol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective response according to RECIST 1.1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Progression free survival<br /><br>Duration of response<br /><br>Time to response<br /><br>Time to progression<br /><br>Overall survival<br /><br>Safety and tolerability of BEZ235</p><br>