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)

September 7, 2020 updated by: OncoMed Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Victoria
      • Bentleigh East, Victoria, Australia, 3165
        • Monash Medical Centre, Moorabbin
      • St Albans, Victoria, Australia, 3021
        • Western Health (Sunshine Hospitals)
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • St John of God Murdoch Hospital
      • Subiaco, Western Australia, Australia, 6008
        • St. John of God Subiaco Hospital
  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1070
        • Hopital Erasme
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre, Odette Cancer Centre
      • Toronto, Ontario, Canada, M6R 1B5
        • St Josephs Health Centre
  • Spain
      • Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marafi6n
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28492
        • Hospital Universitario de Fuenlabrada
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology & Oncology Centre
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center
      • Duarte, California, United States, 91010
        • City of Hope
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center
      • Sacramento, California, United States, 95817
        • University of California, Davis Comprehensive Cancer Center
      • San Marcos, California, United States, 92078
        • Soulhern California Permanente Medical Group
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente NW Oncology Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Sydney Kimmel Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research Treatment Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at the University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Abraxane® and gemcitabine plus placebo
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
Drug: Placebo
Drug: Demcizumab
administered intravenously
Drug: gemcitabine
administered intravenously
Drug: Abraxane®
administered intravenously
EXPERIMENTAL: Abraxane® and gemcitabine plus demcizumab plus placebo
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
Drug: Demcizumab
administered intravenously
Drug: gemcitabine
administered intravenously
Drug: Abraxane®
administered intravenously
EXPERIMENTAL: Abraxane® and gemcitabine plus demcizumab
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
Drug: Demcizumab
administered intravenously
Drug: gemcitabine
administered intravenously
Drug: Abraxane®
administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
Time Frame: Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OncoMed Pharmaceuticals, Inc.

Collaborators

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M18-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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