Back to resultsStudy of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma (YOSEMITE)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Demcizumab
Abraxane®
gemcitabine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring 1st-line metastatic pancreatic ductal adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
- Age ≥21 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
- Adequate organ and marrow function
- Signed Informed Consent Form
- For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria:
- Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
- Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
- Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Subjects with Grade >2 peripheral neuropathy
- Subjects with clinically significant ascites
- Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
- Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
Sites / Locations
- Banner MD Anderson Cancer Center
- Providence Saint Joseph Medical Center
- City of Hope
- Scripps Cancer Center
- University of California, Davis Comprehensive Cancer Center
- Soulhern California Permanente Medical Group
- Kaiser Permanente Medical Center
- Rocky Mountain Cancer Centers
- Lynn Cancer Institute
- University of Iowa Hospitals and Clinics
- University of Kansas Cancer Center
- Ochsner Clinic Foundation
- University of Michigan
- Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
- University of Rochester
- SUNY Upstate Medical University
- Cleveland Clinic
- Kaiser Permanente NW Oncology Research
- Thomas Jefferson University, Sydney Kimmel Cancer Center
- Baylor College of Medicine
- Joe Arrington Cancer Research Treatment Center
- Huntsman Cancer Institute at The University of Utah
- Prince of Wales Hospital
- Monash Medical Centre, Moorabbin
- Western Health (Sunshine Hospitals)
- St John of God Murdoch Hospital
- St. John of God Subiaco Hospital
- Hopital Erasme
- Tom Baker Cancer Centre
- British Columbia Cancer Agency
- QEII Health Sciences Centre
- London Regional Cancer Program
- Sunnybrook Health Sciences Centre, Odette Cancer Centre
- Princess Margaret Hospital
- St Josephs Health Centre
- Hospital Universitario de Fuenlabrada
- Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
- Hospital General Universitario Gregorio Marafi6n
- Hospital Universitario de Fuenlabrada
- Hospital Universitario Miguel Servet
- Bristol Haematology & Oncology Centre
- Sarah Cannon Research Institute UK
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Abraxane® and gemcitabine plus placebo
Abraxane® and gemcitabine plus demcizumab plus placebo
Abraxane® and gemcitabine plus demcizumab
Arm Description
Abraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression
Outcomes
Primary Outcome Measures
Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Secondary Outcome Measures
Full Information
NCT ID
NCT02289898
First Posted
November 10, 2014
Last Updated
September 7, 2020
Sponsor
OncoMed Pharmaceuticals, Inc.
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02289898
Brief Title
Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Acronym
YOSEMITE
Official Title
A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoMed Pharmaceuticals, Inc.
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.
The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
1st-line metastatic pancreatic ductal adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abraxane® and gemcitabine plus placebo
Arm Type
Experimental
Arm Description
Abraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Arm Title
Abraxane® and gemcitabine plus demcizumab plus placebo
Arm Type
Experimental
Arm Description
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Arm Title
Abraxane® and gemcitabine plus demcizumab
Arm Type
Experimental
Arm Description
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression
Intervention Type
Drug
Intervention Name(s)
Demcizumab
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Abraxane®
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
Description
Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Time Frame
Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
Age ≥21 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
Adequate organ and marrow function
Signed Informed Consent Form
For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria:
Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
Subjects with Grade >2 peripheral neuropathy
Subjects with clinically significant ascites
Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
Pregnant women or nursing women
Subjects with known HIV infection
Known bleeding disorder or coagulopathy
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Providence Saint Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Soulhern California Permanente Medical Group
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kaiser Permanente NW Oncology Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Thomas Jefferson University, Sydney Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Joe Arrington Cancer Research Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Huntsman Cancer Institute at The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Monash Medical Centre, Moorabbin
City
Bentleigh East
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Western Health (Sunshine Hospitals)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
St John of God Murdoch Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
St. John of God Subiaco Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Hopital Erasme
City
Brussels
State/Province
Brussels Capital
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre, Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
St Josephs Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28492
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marafi6n
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Bristol Haematology & Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
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