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
YOSEMITE
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
1 other identifier
interventional
207
6 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Apr 2015
Shorter than P25 for phase_2 pancreatic-cancer
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedStudy Start
First participant enrolled
April 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
August 8, 2018
CompletedSeptember 28, 2020
September 1, 2020
2 years
November 10, 2014
May 21, 2018
September 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
Study Arms (3)
Abraxane® and gemcitabine plus placebo
EXPERIMENTALAbraxane® 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 plus placebo
EXPERIMENTALAbraxane® 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
EXPERIMENTALAbraxane® 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
Interventions
administered intravenously
administered intravenously
administered intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OncoMed Pharmaceuticals, Inc.lead
- Celgene Corporationcollaborator
Study Sites (42)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Providence Saint Joseph Medical Center
Burbank, California, 91505, United States
City of Hope
Duarte, California, 91010, United States
Scripps Cancer Center
La Jolla, California, 92037, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Soulhern California Permanente Medical Group
San Marcos, California, 92078, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kaiser Permanente NW Oncology Research
Portland, Oregon, 97227, United States
Thomas Jefferson University, Sydney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, 79410, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, 84112, United States
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Monash Medical Centre, Moorabbin
Bentleigh East, Victoria, 3165, Australia
Western Health (Sunshine Hospitals)
St Albans, Victoria, 3021, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Hopital Erasme
Brussels, Brussels Capital, 1070, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
St Josephs Health Centre
Toronto, Ontario, M6R 1B5, Canada
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28492, Spain
Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
Barcelona, 08916, Spain
Hospital General Universitario Gregorio Marafi6n
Madrid, 28007, Spain
Hospital Universitario de Fuenlabrada
Madrid, 28942, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Bristol Haematology & Oncology Centre
Bristol, BS2 8ED, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John, Lewicki, Chief Scientific Officer
- Organization
- Mereo BioPharma Group Plc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2014
First Posted
November 13, 2014
Study Start
April 20, 2015
Primary Completion
May 1, 2017
Study Completion
September 1, 2017
Last Updated
September 28, 2020
Results First Posted
August 8, 2018
Record last verified: 2020-09