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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)

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ClinicalTrials.gov Identifier: NCT02289898
Recruitment Status : Completed
First Posted : November 13, 2014
Results First Posted : August 8, 2018
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Demcizumab Drug: Abraxane® Drug: gemcitabine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 20, 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Demcizumab
administered intravenously

Drug: Abraxane®
administered intravenously

Drug: gemcitabine
administered intravenously

Drug: Placebo
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: Abraxane®
administered intravenously

Drug: gemcitabine
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: Abraxane®
administered intravenously

Drug: gemcitabine
administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289898


Locations
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Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Celgene Corporation
  Study Documents (Full-Text)

Documents provided by Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. ):
Statistical Analysis Plan  [PDF] March 8, 2017
Study Protocol and Informed Consent Form  [PDF] December 19, 2016

More Information
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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02289898    
Other Study ID Numbers: M18-006
First Posted: November 13, 2014    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: September 28, 2020
Last Verified: September 2020
Keywords provided by Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. ):
1st-line metastatic pancreatic ductal adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Albumin-Bound Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs