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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Stage IV Pancreatic Cancer

In brief

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.

Key facts

Study ID

NCT01647828

Run by

OncoMed Pharmaceuticals, Inc.

People needed

217

Starts

2012-10-01

Expected to finish

2016-04-01

Last updated by the study team

2023-02-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following major inclusion criteria to be eligible for the study:
• 18 years of age or older
• Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
• Performance Status (ECOG) 0 or 1
• FFPE tumor tissue from metastatic site(s
• Adequate organ function
• Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
• 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.
• 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.

You may not qualify if…

• Subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study:
• Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.
• Known brain metastases.
• Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
• 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).
• Any disorder that would significantly compromise protocol compliance.
• 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.
• Known human immunodeficiency virus (HIV) infection.
• Females who are pregnant or breastfeeding.

Where it is running

• 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

Full record on ClinicalTrials.gov

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