Pancreas CancerPhase 2NCT00300950
Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer
A Phase 2 study testing GI-4000 and Gemcitabine in people with Pancreas Cancer, run by GlobeImmune at 28 sites in 2 countries.
Trial summary
The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- GI-4000 and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Jan 2006to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
- >18 years of age
- Negative skin test for hypersensitivity to Saccharomyces cerevisiae
Who cannot join
- Metastatic pancreas cancer patients post-resection
- Patients with no product-related ras mutation.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States18 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35294
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Rush University Medical School
Chicago, Illinois, 60612
Ohio State University
Columbus, Ohio, 43210
Texas Oncology, PA
Dallas, Texas, 75231
The Texas Cancer Center Dallas Southwest
Dallas, Texas, 75237
Baylor College of Medicine
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093
UCLA Medical Center
Los Angeles, California, 90095
Froedtert Multi-Disciplinary Cancer Clinic
Milwaukee, Wisconsin, 53226
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404
South Texas Oncology & Hematology
San Antonio, Texas, 78229
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
State University of NY at Stony Brook
Stony Brook, New York, 11794
Tyler Cancer Center
Tyler, Texas, 75702
Georgetown University Medical Center / Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
India10 sites
Indo American Cancer Hospital and Research Centre
Hyderabad, 500034
KMC Hospital
Mangalore, 575001
Govt Medical Colleg & Hospital
Nagpur
Lake Shore Hospital & Research Centre
Nettoor, Cochin, 682304
G B Pan Hospital & Maulana Azad Medical College
New Delhi, 110002
Nizam's Institute of Medical Sciences
Panjagutta, Hyderaba, 500082
PSG Hospitals
Peelamedu, Coimbatore, Tamil Nadu, 641004
Lifeline Multispecialty Hospital
Perungudi, Chennai, 600096
Sri Ramchandra Medical College & Research Institute
Ponur, Chennai, Tamil Nadu, 600116
Regional Cancer Centre
Trivandrum, 695011
About this study
Official title: A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.
The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.
- Conditions
- Pancreas Cancer
- Being tested
- GI-4000, Gemcitabine
- Keywords
- Pancreas Cancer, resected pancreas cancer, non-metastatic pancreas cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-4000Biological
Heat-killed yeast cell transfected with target ras mutation.
GemcitabineDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gencitabine Receives: Biological: GI-4000 |
| 2 | Experimental | Gemcitabine with GI-4000 Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free time and survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlobeImmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300950
- Sponsor's protocol ID
- GI-4000-02
- Status last verified
- Apr 2015
- First submitted
- 8 Mar 2006
- Last updated
- 6 Apr 2015
- Results posted
- No
Publications
Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021.
PubMed 33786412
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.
- ClinicalTrials.gov ID
- NCT00300950
- Acronym / sponsor ID
- GI-4000-02
- Conditions
- Pancreas Cancer
- Keywords
- Pancreas Cancer, resected pancreas cancer, non-metastatic pancreas cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- GlobeImmuneIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: GI-4000Gencitabine |
| 2 | Experimental | Drug: GemcitabineGemcitabine with GI-4000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
- >18 years of age
- Negative skin test for hypersensitivity to Saccharomyces cerevisiae
Key exclusion criteria (2 listed)
- Metastatic pancreas cancer patients post-resection
- Patients with no product-related ras mutation.
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 |
|---|---|---|
| GI-4000Heat-killed yeast cell transfected with target ras mutation. | Biological | 1 |
| GemcitabineChemotherapy | Drug | 2 |
Primary outcome
Recurrence free time and survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Derived from this study: PubMed 33786412Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021.
- Sponsor websiteLink provided by the sponsor.
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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.
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GI-4000 and Gemcitabine in people with Pancreas Cancer, run by GlobeImmune at 28 sites in 2 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 3 inclusion and 2 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 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence free time and survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300950, which also lists 1 linked publication.
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 6 Apr 2015.