Pancreatic Cancer Clinical Trial
— YOSEMITEOfficial 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
Verified date | September 2020 |
Source | Mereo BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 207 |
Est. completion date | September 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. 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. 3. Age =21 years 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1 5. Adequate organ and marrow function 6. Signed Informed Consent Form 7. For women of childbearing potential, agreement to use two effective forms of contraception Exclusion Criteria: 1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies. 2. 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. 3. Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease 4. Subjects with Grade >2 peripheral neuropathy 5. Subjects with clinically significant ascites 6. 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 7. 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 8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy 9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease 10. Pregnant women or nursing women 11. Subjects with known HIV infection 12. Known bleeding disorder or coagulopathy |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Medical Centre, Moorabbin | Bentleigh East | Victoria |
Australia | St John of God Murdoch Hospital | Murdoch | Western Australia |
Australia | Prince of Wales Hospital | Randwick | New South Wales |
Australia | Western Health (Sunshine Hospitals) | St Albans | Victoria |
Australia | St. John of God Subiaco Hospital | Subiaco | Western Australia |
Belgium | Hopital Erasme | Brussels | Brussels Capital |
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | London Regional Cancer Program | London | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | St Josephs Health Centre | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre, Odette Cancer Centre | Toronto | Ontario |
Canada | British Columbia Cancer Agency | Vancouver | British Columbia |
Spain | Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO) | Barcelona | |
Spain | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid |
Spain | Hospital General Universitario Gregorio Marafi6n | Madrid | |
Spain | Hospital Universitario de Fuenlabrada | Madrid | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
United Kingdom | Bristol Haematology & Oncology Centre | Bristol | |
United Kingdom | Sarah Cannon Research Institute UK | London | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Lynn Cancer Institute | Boca Raton | Florida |
United States | Providence Saint Joseph Medical Center | Burbank | California |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Rocky Mountain Cancer Centers | Denver | Colorado |
United States | City of Hope | Duarte | California |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Scripps Cancer Center | La Jolla | California |
United States | Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Joe Arrington Cancer Research Treatment Center | Lubbock | Texas |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Thomas Jefferson University, Sydney Kimmel Cancer Center | Philadelphia | Pennsylvania |
United States | Kaiser Permanente NW Oncology Research | Portland | Oregon |
United States | University of Rochester | Rochester | New York |
United States | University of California, Davis Comprehensive Cancer Center | Sacramento | California |
United States | Huntsman Cancer Institute at The University of Utah | Salt Lake City | Utah |
United States | Soulhern California Permanente Medical Group | San Marcos | California |
United States | SUNY Upstate Medical University | Syracuse | New York |
United States | Kaiser Permanente Medical Center | Vallejo | California |
United States | University of Kansas Cancer Center | Westwood | Kansas |
Lead Sponsor | Collaborator |
---|---|
OncoMed Pharmaceuticals, Inc. | Celgene Corporation |
United States, Australia, Belgium, Canada, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
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