Trial Condition(s):

Ovarian Neoplasms

Phase Ib study of anetumab ravtansine in combination with pegylated liposomal doxorubicin in patients with recurrent mesothelin-expressing platinum-resistant cancer

Bayer Identifier:

18326

ClinicalTrials.gov Identifier:

NCT02751918

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Anetumab ravtansine is developed for the treatment of patients with recurrent platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated liposomal doxorubicin in this indication.

Inclusion Criteria
- Subjects with locally invasive or metastatic, epithelial  ovarian, fallopian tube, or primary peritoneal cancer
- Subjects must provide samples of tumor tissue
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer
- Women who are pregnant or breast feeding
- Subjects who have an active hepatitis B virus or hepatitis C virus infection requiring treatment as defined in the protocol

Trial Summary

Enrollment Goal
65
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Oklahoma University Health Science Center

Oklahoma City, United States, 73104

Status
Completed
 
Locations

Yale University School of Medicine

New Haven, United States, 06520-8064

Status
Completed
 
Locations

The Institute of Oncology

Chisinau, Moldova, 2025

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Clinica Universidad de Navarra CUN en Madrid

Madrid, Spain, 28027

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Instituto Valenciano de Oncología

Valencia, Spain, 46009

Status
Completed
 
Locations

Rocky Mountain Cancer Centers

Aurora, United States, 80012

Status
Completed
 
Locations

Clínica Universidad de Navarra CUN

Pamplona, Spain, 31008

Status
Completed
 

Trial Design