Clinical trial NCT02289898: 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: 1st-line metastatic pancreatic ductal adenocarcinoma
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
First posted: 2014-11-13
Enrollment: 207
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
timeFrame: Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center
state: California
city: San Marcos
country: United States
facility: Soulhern California Permanente Medical Group
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
state: New Hampshire
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente NW Oncology Research
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Sydney Kimmel Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research Treatment Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at The University of Utah
state: Utah
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Bentleigh East
country: Australia
facility: Monash Medical Centre, Moorabbin
state: Victoria
city: St Albans
country: Australia
facility: Western Health (Sunshine Hospitals)
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: St. John of God Subiaco Hospital
state: Western Australia
city: Brussels
country: Belgium
facility: Hopital Erasme
state: Brussels Capital
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: St Josephs Health Centre
state: Ontario
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marafi6n
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bristol
country: United Kingdom
facility: Bristol Haematology & Oncology Centre
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
Study officials:
References: