Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer



Status:Recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:June 8, 2016
End Date:February 28, 2021
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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An Open-label Phase Ib Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Maximum Tolerated Dose of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin 30 mg/m2 Given Every 3 Weeks in Subjects With Mesothelin-expressing Platinum-resistant Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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
We found this trial at
7
sites
Oklahoma City, Oklahoma 73104
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Aurora, Colorado 80012
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Aurora, CO
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Eugene, Oregon 97401
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Eugene, OR
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49 Herestraat
Leuven, 3000
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Leuven,
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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