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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pancreatic Cancer

In brief

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 in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.

Key facts

Study ID

NCT02289898

Run by

OncoMed Pharmaceuticals, Inc.

People needed

207

Starts

2015-04-20

Expected to finish

2017-09-01

Last updated by the study team

2020-09-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Providence Saint Joseph Medical Center — Burbank, California, United States
• City of Hope — Duarte, California, United States
• Scripps Cancer Center — La Jolla, California, United States
• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States
• Soulhern California Permanente Medical Group — San Marcos, California, United States
• Kaiser Permanente Medical Center — Vallejo, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
• University of Rochester — Rochester, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Kaiser Permanente NW Oncology Research — Portland, Oregon, United States
• Thomas Jefferson University, Sydney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Joe Arrington Cancer Research Treatment Center — Lubbock, Texas, United States
• Huntsman Cancer Institute at The University of Utah — Salt Lake City, Utah, United States
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Monash Medical Centre, Moorabbin — Bentleigh East, Victoria, Australia
• Western Health (Sunshine Hospitals) — St Albans, Victoria, Australia

Full record on ClinicalTrials.gov

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