Pancreatic CancerPhase 3NCT00044031
Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma
A Phase 3 study testing G17DT Immunogen in people with Pancreatic Cancer, run by Cancer Advances Inc..
Trial summary
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- G17DT Immunogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Oct 2007
- Phase
- Phase 3
- 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
- Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
- Life expectancy of at least 3 months
- Functional status by Karnofsky Index of at least 70
Who cannot join
- Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
- Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
- Immunodeficiency
- Bone marrow transplant within past year
- Brain metastasis
About this study
Official title: Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- G17DT Immunogen
- Keywords
- pancreatic cancer, G17DT, gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G17DT ImmunogenBiological
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Placebo (immunogen vehicle) combined with gemcitabine. |
| A | Experimental | 500 µg G17DT immunogen combined with gemcitabine. Receives: Biological: G17DT Immunogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Up to 12 months
Secondary outcomes (1)
Number of Participants with Serious and Non-Serious Adverse Events
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2002 (estimated)
- Study startFeb 2001
- Primary completionApr 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Advances Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R Hawkins, M.D., Principal investigator, Christie Hospital, Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044031
- Sponsor's protocol ID
- PC4
- Status last verified
- Apr 2014
- First submitted
- 16 Aug 2002
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)
- ClinicalTrials.gov ID
- NCT00044031
- Acronym / sponsor ID
- PC4
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, G17DT, gemcitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Aug 2002 (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.
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | –Placebo (immunogen vehicle) combined with gemcitabine. |
| A | Experimental | Biological: G17DT Immunogen500 µg G17DT immunogen combined with gemcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
- Life expectancy of at least 3 months
- Functional status by Karnofsky Index of at least 70
Key exclusion criteria (5 listed)
- Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
- Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
- Immunodeficiency
- Bone marrow transplant within past year
- Brain metastasis
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 |
|---|---|---|
| G17DT Immunogen | Biological | A |
Primary outcome
Survival
Time frame: Up to 12 months
1 secondary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 12 months
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 17 Apr 2014.
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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.
R Hawkins, M.D. principal investigator
Christie Hospital, Manchester
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing G17DT Immunogen in people with Pancreatic Cancer, run by Cancer Advances Inc..
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 5 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Survival (time frame: Up to 12 months). 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 17 Apr 2014.