A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
NCT ID: NCT01647828
Last Updated: 2023-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
217 participants
INTERVENTIONAL
2012-10-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
OMP-59R5
OMP-59R5 administered intravenously
Gemcitabine
administered intravenously
Nab-Paclitaxel
administered intravenously
Gemcitabine and Nab-Paclitaxel plus Placebo
Gemcitabine and Nab-Paclitaxel plus Placebo
Gemcitabine
administered intravenously
Placebo
administered IV
Nab-Paclitaxel
administered intravenously
Interventions
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OMP-59R5
OMP-59R5 administered intravenously
Gemcitabine
administered intravenously
Placebo
administered IV
Nab-Paclitaxel
administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
3. Performance Status (ECOG) 0 or 1
4. FFPE tumor tissue from metastatic site(s
5. Adequate organ function
6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
7. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
8. Male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
Exclusion Criteria
2. Known brain metastases.
3. Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
5. Any disorder that would significantly compromise protocol compliance.
6. Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
7. Known human immunodeficiency virus (HIV) infection.
8. Females who are pregnant or breastfeeding.
18 Years
90 Years
ALL
No
Sponsors
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OncoMed Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eileen M O'Reilly, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Western Regional Medical Center, Inc.
Goodyear, Arizona, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States
St Jude Heritage Healthcare Virginia K. Crosson Cancer Center
Fullerton, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Ronald Reagan UCLA Medical Center, Drug Information Center, Department of Pharmaceutical Services
Los Angeles, California, United States
Torrance Health Association Dba Torrance Memorial Physician Network/Cancer Care Associates
Redondo Beach, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Orlando Health, Inc.
Orlando, Florida, United States
Northside Hospital, Inc. - GCS/Almex
Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers ofNevada
Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Bend Memorial Clinic
Bend, Oregon, United States
Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research
Greenville, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
South Texas Accelerated Research Thereapeutics, LLC (START)
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Wiscons in Hospi tal and Clinics
Madison, Wisconsin, United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Hu ZI, Bendell JC, Bullock A, LoConte NK, Hatoum H, Ritch P, Hool H, Leach JW, Sanchez J, Sohal DPS, Strickler J, Patel R, Wang-Gillam A, Firdaus I, Yu KH, Kapoun AM, Holmgren E, Zhou L, Dupont J, Picozzi V, Sahai V, O'Reilly EM. A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer. Cancer Med. 2019 Sep;8(11):5148-5157. doi: 10.1002/cam4.2425. Epub 2019 Jul 26.
Other Identifiers
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59R5-002
Identifier Type: -
Identifier Source: org_study_id
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