Pancreatic CancerPhase 2YOSEMITENCT02289898
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
A Phase 2 study testing Demcizumab, Abraxane® and gemcitabine in people with Pancreatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 42 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Demcizumab, Abraxane® and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 42 sitesin 6 countries
- Study dates
- 20 Apr 2015to Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
Lynn Cancer Institute
Boca Raton, Florida, 33486
Providence Saint Joseph Medical Center
Burbank, California, 91505
Cleveland Clinic
Cleveland, Ohio, 44195
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
City of Hope
Duarte, California, 91010
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Scripps Cancer Center
La Jolla, California, 92037
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, 79410
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Thomas Jefferson University, Sydney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Kaiser Permanente NW Oncology Research
Portland, Oregon, 97227
University of Rochester
Rochester, New York, 14642
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, 84112
Soulhern California Permanente Medical Group
San Marcos, California, 92078
SUNY Upstate Medical University
Syracuse, New York, 13210
Kaiser Permanente Medical Center
Vallejo, California, 94589
University of Kansas Cancer Center
Westwood, Kansas, 66205
Canada7 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
London Regional Cancer Program
London, Ontario, N6A 4L6
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
St Josephs Health Centre
Toronto, Ontario, M6R 1B5
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Australia5 sites
Monash Medical Centre, Moorabbin
Bentleigh East, Victoria, 3165
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Prince of Wales Hospital
Randwick, New South Wales, 2031
Western Health (Sunshine Hospitals)
St Albans, Victoria, 3021
St. John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Spain5 sites
Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO)
Barcelona, 08916
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28492
Hospital General Universitario Gregorio Marafi6n
Madrid, 28007
Hospital Universitario de Fuenlabrada
Madrid, 28942
Hospital Universitario Miguel Servet
Zaragoza, 50009
United Kingdom2 sites
Bristol Haematology & Oncology Centre
Bristol, BS2 8ED
Sarah Cannon Research Institute UK
London, W1G 6AD
About this study
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
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Demcizumab, Abraxane®, gemcitabine, Placebo
- Keywords
- 1st-line metastatic pancreatic ductal adenocarcinoma
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DemcizumabDrug
administered intravenously
Abraxane®Drug
administered intravenously
gemcitabineDrug
administered intravenously
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Abraxane® and gemcitabine plus placebo | Experimental | 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 Receives: Drug: Demcizumab; Drug: Abraxane®; Drug: gemcitabine; Drug: Placebo |
| Abraxane® and gemcitabine plus demcizumab plus placebo | Experimental | 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 Receives: Drug: Demcizumab; Drug: Abraxane®; Drug: gemcitabine |
| Abraxane® and gemcitabine plus demcizumab | Experimental | 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 Receives: Drug: Demcizumab; Drug: Abraxane®; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study start20 Apr 2015
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289898
- Sponsor's protocol ID
- M18-006
- Acronym
- YOSEMITE
- Status last verified
- Sep 2020
- First submitted
- 10 Nov 2014
- Last updated
- 28 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02289898
- Acronym / sponsor ID
- YOSEMITE / M18-006
- Conditions
- Pancreatic Cancer
- Keywords
- 1st-line metastatic pancreatic ductal adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abraxane® and gemcitabine plus placebo | Experimental | Drug: Demcizumab, Drug: Abraxane®, Drug: gemcitabine, Drug: PlaceboAbraxane® 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 |
| Abraxane® and gemcitabine plus demcizumab plus placebo | Experimental | Drug: Demcizumab, Drug: Abraxane®, Drug: gemcitabineAbraxane® 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 |
| Abraxane® and gemcitabine plus demcizumab | Experimental | Drug: Demcizumab, Drug: Abraxane®, Drug: gemcitabineAbraxane® 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demcizumabadministered intravenously | Drug | Abraxane® and gemcitabine plus demcizumab, Abraxane® and gemcitabine plus demcizumab plus placebo, Abraxane® and gemcitabine plus placebo |
| Abraxane®administered intravenously | Drug | Abraxane® and gemcitabine plus demcizumab, Abraxane® and gemcitabine plus demcizumab plus placebo, Abraxane® and gemcitabine plus placebo |
| gemcitabineadministered intravenously | Drug | Abraxane® and gemcitabine plus demcizumab, Abraxane® and gemcitabine plus demcizumab plus placebo, Abraxane® and gemcitabine plus placebo |
| Placebo | Drug | Abraxane® and gemcitabine plus placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Demcizumab, Abraxane® and gemcitabine in people with Pancreatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 42 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Canada, Australia, Spain, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.