Trial record 1 of 4 for:
YOSEMITE
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 |
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Recruitment Status :
Completed
First Posted : November 13, 2014
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
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Sponsor:
OncoMed Pharmaceuticals, Inc.
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
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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 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
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Demcizumab
administered intravenously Drug: Abraxane® administered intravenously Drug: gemcitabine administered intravenously Drug: Placebo |
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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 |
Primary Outcome Measures :
- 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.
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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:
- 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.
- 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.
- Age ≥21 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
- Adequate organ and marrow function
- Signed Informed Consent Form
- For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria:
- Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
- 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.
- Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Subjects with Grade >2 peripheral neuropathy
- Subjects with clinically significant ascites
- 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
- 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
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
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
Show 42 study locations
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Celgene Corporation
Study Documents (Full-Text)
Documents provided by OncoMed Pharmaceuticals, Inc.:
Documents provided by OncoMed Pharmaceuticals, Inc.:
Statistical Analysis Plan [PDF] March 8, 2017
Study Protocol and Informed Consent Form [PDF] December 19, 2016
| 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: | August 8, 2018 |
| Last Verified: | July 2018 |
Keywords provided by OncoMed Pharmaceuticals, Inc.:
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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 |