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 |
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.
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
1515 Holcombe Blvd
Houston, Texas 77030
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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University of Southern California The University of Southern California is one of the world’s leading...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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3800 Reservoir Rd NW
Washington, District of Columbia 20007
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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