A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
| Status: | Completed | 
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 9/20/2018 | 
| Start Date: | May 2015 | 
| End Date: | August 2018 | 
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
The purpose of this study is to determine whether the combination of MM-141 plus
nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone
based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients
with high serum levels of free IGF-1.
			nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone
based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients
with high serum levels of free IGF-1.
This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line
metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status.
Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients.
Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise
eligible will be followed in an observational group.
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line
metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status.
Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients.
Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise
eligible will be followed in an observational group.
Inclusion Criteria:
- Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not
eligible.
- Patient must have received no prior radiotherapy, surgery, chemotherapy, or
investigational therapy for the treatment of metastatic disease.
- Blood sample sent for free IGF-1 testing
- ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
- Patients who only present with localized disease
- Patients with CNS malignancies (primary or metastatic)
- Clinically significant cardiac disease
We found this trial at
    48
    sites
	
								Pembroke Pines, Florida 33028			
	
			
					Principal Investigator: Pablo Ferraro, MD
			
						
										Phone: 954-265-1864
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									2220 Pierce Ave
Nashville, Tennessee 37232
	
			Nashville, Tennessee 37232
615-936-8422 
							
					Principal Investigator: Emily Chan, MD
			
						
										Phone: 615-875-0060
					
		Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...  
  
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									116th St and Broadway
New York, New York 10027
	
			New York, New York 10027
(212) 854-1754
							
					Principal Investigator: Paul Oberstein, MD
			
						
										Phone: 212-342-0248
					
		Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...  
  
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								Bethlehem, Pennsylvania 			
	
			
					Principal Investigator: Asim Ali, MD
			
						
										Phone: 484-526-3589
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								Buffalo, New York 14263			
	
			
					Principal Investigator: Wen Wee Ma, MD
			
						
										Phone: 716-845-8309
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									303 East Superior Street
Chicago, Illinois 60611
	
			
					Chicago, Illinois 60611
Principal Investigator: Halla Nimeiri, MD
			
						
										Phone: 312-695-1102
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									 2035 W Taylor St
Chicago, Illinois
	
			Chicago, Illinois
(312) 996-4350
							
					Principal Investigator: Arkadiusz Dudek, MD
			
						
										Phone: 312-413-1902
					
		University of Illinois at Chicago A major research university in the heart of one of...  
  
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								East Setauket, New York 11733			
	
			
					Principal Investigator: David Chu, MD
			
						
										Phone: 631-675-5143
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									8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
	
			Fairfax, Virginia 22031
(703) 280-5390
							
					
		Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...  
  
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								Fullerton, California 92835			
	
			
					Principal Investigator: David Park, MD
			
						
										Phone: 714-446-5364
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								Gilbert, Arizona 85234			
	
			
					Principal Investigator: Madappa N. Kundranda, MD
			
						
										Phone: 480-256-4649
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								Lafayette, Louisiana 70503			
	
			
					Principal Investigator: Salman Malad, MD
			
						
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								Los Angeles, California 			
	
			
					Principal Investigator: Randolph Hecht, MD
			
						
										Phone: 310-633-8400
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		Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...  
  
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								Newnan, Georgia 30265			
	
			
					Principal Investigator: Eyal Meiri, MD
			
						
										Phone: 770-400-7191
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								Park Ridge, Illinois 60068			
	
			
					Principal Investigator: Edward James, MD
			
						
										Phone: 847-410-0667
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								Philadelphia, Pennsylvania 19111			
	
			
					Principal Investigator: Crystal Denlinger, MD
			
						
										Phone: 215-214-1685
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								Redondo Beach, California 90277			
	
			
					Principal Investigator: Hugo Hool, MD
			
						
										Phone: 310-750-3376
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								San Francisco, California 94115			
	
			
					Principal Investigator: Andrew Ko, MD
			
						
										Phone: 415-353-7284
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								Santa Barbara, California 93105			
	
			
					Principal Investigator: Gregg Newman, MD
			
						
										Phone: 805-898-3602
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								Santa Maria, California 93454			
	
			
					Principal Investigator: Robert Dichmann, MD
			
						
										Phone: 805-346-3461
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								Spokane Valley, Washington 99216			
	
			
					Principal Investigator: Danko Martincic, MD
			
						
										Phone: 509-228-1188
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		Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...  
  
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								Worcester, Massachusetts 01608			
	
			
					Principal Investigator: James Rooney, MD
			
						
										Phone: 508-556-5431
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