Status:
COMPLETED
Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
OncoMed Pharmaceuticals, Inc.
Collaborating Sponsors:
Celgene Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. The purpose is to test the efficacy and safety of demcizumab, when given...
Eligibility Criteria
Inclusion
- Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
- Age ≥21 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
- Adequate organ and marrow function
- Signed Informed Consent Form
- For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion
- Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
- Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
- Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Subjects with Grade \>2 peripheral neuropathy
- Subjects with clinically significant ascites
- Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
- Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
Key Trial Info
Start Date :
April 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT02289898
Start Date
April 20 2015
End Date
September 1 2017
Last Update
September 28 2020
Active Locations (42)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
3
City of Hope
Duarte, California, United States, 91010
4
Scripps Cancer Center
La Jolla, California, United States, 92037