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 |
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.
(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
Redondo Beach, California 90277
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
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University of Michigan Health System The University of Michigan is home to one of the...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Greenville, South Carolina 29605
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Los Angeles, California 90095
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
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Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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