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
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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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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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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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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Pittsburgh, Pennsylvania 15232
Principal Investigator: Nathan Bahary
Phone: 412-864-7764
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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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