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 | 
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.
			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
	
								Nashville, Tennessee 37203			
	
			
					Principal Investigator: SMO Sarah Cannon Research Inst.
			
						
										Phone: 615-329-7274
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									666 Elm Street
Buffalo, New York 14263
	
			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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									3840 Broadway
Fort Myers, Florida 33901
	
			Fort Myers, Florida 33901
(239) 275-6400
							 
					Principal Investigator: Faithlore P Gardner
			
						
										Phone: 239-274-9930
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									1211 Medical Center Dr
Nashville, Tennessee 37232
	
			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
	
			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
	
			
					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
	
			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
	
			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
	
			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
	
			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
	
			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
	
			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
	
			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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								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
	
			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
	
			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
	
			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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