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

Pancreatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289898
• Other study ID #: M18-006
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer

Intervention

Drug:
• Demcizumab
administered intravenously
• Abraxane®
administered intravenously
• gemcitabine
administered intravenously
• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
OncoMed Pharmaceuticals, Inc.	Celgene Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Spain,  United Kingdom, 

Outcome

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).