A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:October 2012
End Date:September 2016

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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.


Inclusion Criteria:

Subjects must meet all of the following major inclusion criteria to be eligible for the
study:

1. 18 years of age or older

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:

Subjects who meet any of the following major exclusion criteria will not be eligible for
participation in the study:

1. Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.

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.
We found this trial at
26
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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24 Sturtevant St
Orlando, Florida 32806
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1500 E Medical Center Dr
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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Atlanta, Georgia 30341
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Bend, Oregon 97701
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Denver, Colorado 80218
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Goodyear, Arizona 85338
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Las Vegas, Nevada 89128
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Long Beach, California 90813
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Minneapolis, Minnesota 55407
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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St. Louis, Missouri 63108
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