A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 22, 2017
End Date:May 31, 2022
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer

The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and
gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic
cancer.


Inclusion Criteria:

- Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that
is metastatic (Stage IV) and not amenable to resection with curative intent.

- If present, clinically significant or symptomatic amounts of ascites should be drained
prior to Day 1.

- Have had no prior systemic treatment for metastatic disease. Prior adjuvant or
neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed
if completed ≥3 months prior to enrollment and no lingering toxicities are present.

- Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.

- Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.

- Measurable or nonmeasurable but evaluable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST 1.1).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Discontinued all previous treatments for cancer ≥4 weeks prior.

- Adequate organ function.

- Life expectancy of at least 3 months.

Exclusion Criteria:

- Serious concomitant systemic disorder.

- Have received first line treatment for metastatic pancreatic cancer.

- Received prior treatment with nab-paclitaxel.

- Have known central nervous system malignancy or metastasis.

- Current hematologic malignancies.

- Participated within the last 30 days in a clinical trial involving an investigational
product.

- Women with a positive pregnancy test or lactating.

- Have endocrine pancreatic tumors or ampullary cancer.

- Currently enrolled in another clinical trial.

- Have a known additional malignancy that is progressing or required active treatment
within the past 1 year.

- Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug
formulations.

- Are taking certain anti-coagulant medications such as warfarin and are unable to be
switched to other similar medicines.
We found this trial at
34
sites
Pittsburgh, Pennsylvania 15232
Principal Investigator: Nathan Bahary
Phone: 412-864-7764
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Christos Fountzilas
Phone: 716-845-1912
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Faithlore P Gardner
Phone: 239-274-9930
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Fort Myers, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dana B Cardin
Phone: 877-936-8422
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Sukeshi Arora
Phone: 210-450-1015
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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220 S Palisade Dr # 204
Santa Maria, California 93454
Principal Investigator: Robert Alan Dichmann
Phone: 8057393724
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Bakersfield, California 93309
Principal Investigator: David Eduardo Kanamori
Phone: 6618627158
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Berlin, 13353
Principal Investigator: Uwe Pelzer
Phone: 4930450553737
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Berlin,
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Carolyn Britten
Phone: 843-792-4271
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chattanooga, Tennessee 37404
Principal Investigator: Mark S Womack IV
Phone: 423-242-2858
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph T Beck
Phone: 479-587-1700
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Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 317-436-0800
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Fullerton, California 92835
Principal Investigator: David J Park
Phone: 714-446-5900
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Joseph F Stilwill
Phone: 816-276-3568
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
Principal Investigator: Tony Philip
Phone: 516-734-8940
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Fadi S Braiteh
Phone: 702-952-3400
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Kathryn Hourdequin
Phone: 603-650-6380
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Los Angeles, California 90024
Principal Investigator: SMO TRIO -Translational Research
Phone: 310-794-6500
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Zev Wainberg
Phone: 310-829-5471
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Madison, Wisconsin 53705
Principal Investigator: Nataliya Uboha
Phone: 608-265-9966
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
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New Brunswick, New Jersey 08903
Principal Investigator: Kristen Spencer
Phone: 732-235-3378
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New Haven, Connecticut 06520
Principal Investigator: Jill Lacy
Phone: 203-785-7043
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Principal Investigator: Timothy K Huyck
Phone: 402-354-8124
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Atrayee Basu-Mallick
Phone: 215-503-7660
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Saint Petersburg, Florida 33705
Principal Investigator: Sunil G Gandhi
Phone: 727-216-1143
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Salt Lake City, Utah 84132
Principal Investigator: Ignacio Garrido Laguna
Phone: 801-585-1435
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Santa Barbara, California 93105
Principal Investigator: Gregg C. Newman
Phone: 805-879-0670
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Scottsdale, Arizona 85258
Principal Investigator: Erkut Borazanci
Phone: 480-323-1339
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Sioux Falls, South Dakota 57104
Principal Investigator: Jonathan Bleeker
Phone: 605-328-8000
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Tampa, Florida 33612
Principal Investigator: DaeWon Kim
Phone: 813-745-1277
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Tucson, Arizona 85724
Principal Investigator: Hani Babiker
Phone: 520-626-2620
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Principal Investigator: Shaker Dakhil
Phone: 316-262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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