Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:May 26, 2017
End Date:July 28, 2021
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

The key purpose of the main part of the study is to assess efficacy and safety of anetumab
ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid
tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the
safety and tolerability of anetumab ravtansine in combination with cisplatin and in
combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination
with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with
gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most
indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab
ravtansine is administered in combination with cisplatin or gemcitabine respectively (both
administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal
is met. .Efficacy will be measured by evaluating the tumor's objective response rate.
Radiological tumor assessments will be performed at defined time points until the patient's
disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival
or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker
analyses.


Inclusion Criteria:

- Availability of tumor tissue for mesothelin expression testing and for further
biomarker analysis

- Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic
disease (tumour type specific inclusion criteria)

- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per
International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria

- Adequate bone marrow, liver, renal and coagulation function

- Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN)
according to local institutional ranges

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

- Exposure to more than one prior anti-tubulin/microtubule agent

- Corneal epitheliopathy or any eye disorder that may predispose the patients to this
condition

- Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis

- Contraindication to both CT and MRI contrast agents

- Active hepatitis B or C infection

- Pregnant or breast-feeding patients

- Tumor type specific exclusion criteria
We found this trial at
18
sites
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Bethesda, Maryland
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166-174 Hawkesbury Road
Blacktown, New South Wales 2145
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Dallas, Texas 75246
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31995 Northwestern Highway
Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Gilbert, Arizona 85234
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Gilbert, AZ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Indianapolis, Indiana 46202
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Jacksonville, Florida 32216
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1514 Jefferson Highway
New Orleans, Louisiana 70121
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Phoenix, Arizona
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Stanford, California 94304
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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