Pancreatic CancerPhase 3NCT03200821
An Open Label Study to Evaluate G17DT Compared to Gemcitabine
A Phase 3 study testing G17DT and Gemcitabine in people with Pancreatic Cancer, run by Cancer Advances Inc..
Trial summary
In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced 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 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2000to 19 Sep 2002
- 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
- A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
- A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
- Male or female patients over 18 years of age.
- Laboratory values within the following ranges at screening:
- Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN
- A life expectancy of at least 2 months.
- A negative pregnancy test at the screening visit (females of childbearing potential only).
- Signed written informed consent.
Who cannot join
- History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
- Previous cytotoxic chemotherapy (including gemcitabine).
- Previous radiotherapy within 30 days of baseline.
- Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
- Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
- Participation in another study involving an investigational drug within 90 days of baseline.
About this study
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer
In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- 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.
G17DTBiological
Also called PAS, Polyclonal Antibody Stimulator
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
GemcitabineDrug
Also called Gemzar
1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
| Study group | Role | What they receive |
|---|---|---|
| G17DT | Experimental | 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. Receives: Biological: G17DT |
| Gemcitabine | Active comparator | 1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest. Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival in days measured starting at Baseline
Measured: Baseline (Week 0) up to Week 52 or death.
Secondary outcomes (5)
Tumor Response
The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST).
(RECIST) guidelines
Measured: Weeks 0, 12, 24, 36 and 52
Quality of Life
Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire
Measured: Weeks 0, 6, 12, 24, 36 and 52
Quality of Life
Quality of life measured using and the EORTC QLQ-PAN26 questionnaire
Measured: Weeks 0, 6, 12, 24, 36 and 52
Karnofsky Performance Status
Functional impairment assessment using the Karnofsky Performance Scale Index
Measured: Week 0 to Week 52
Gastrin-17 Antibodies
Antibody assessment to determine serum levels of Gastrin -17 antibodies
Measured: Weeks 0, 6, 12, 24, 36 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start14 Aug 2000
- Primary completion24 Sep 2001
- Study completion19 Sep 2002
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
- Model description
- A randomized, open, parallel group, active comparator
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Advances Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200821
- Sponsor's protocol ID
- PC3
- Status last verified
- Jun 2017
- First submitted
- 30 May 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03200821
- Acronym / sponsor ID
- PC3
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2000 (actual)
- Primary completion
- 24 Sep 2001 (actual)
- Study completion
- 19 Sep 2002 (actual)
- First posted
- 27 Jun 2017 (actual)
- 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.
In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open, parallel group, active comparator
| Arm | Type | Receives |
|---|---|---|
| G17DT | Experimental | Biological: G17DT250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. |
| Gemcitabine | Active comparator | Drug: Gemcitabine1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
- A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
- Male or female patients over 18 years of age.
- Laboratory values within the following ranges at screening:
- Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN
Key exclusion criteria (6 listed)
- History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
- Previous cytotoxic chemotherapy (including gemcitabine).
- Previous radiotherapy within 30 days of baseline.
- Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
- Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
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 |
|---|---|---|
| G17DTAlso: PAS, Polyclonal Antibody Stimulator250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. | Biological | G17DT |
| GemcitabineAlso: Gemzar1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest. | Drug | Gemcitabine |
Primary outcome
Survival
Time frame: Baseline (Week 0) up to Week 52 or death.
Survival in days measured starting at Baseline
5 secondary outcomes
Tumor Response
Time frame: Weeks 0, 12, 24, 36 and 52
Quality of Life
Time frame: Weeks 0, 6, 12, 24, 36 and 52
Quality of Life
Time frame: Weeks 0, 6, 12, 24, 36 and 52
Karnofsky Performance Status
Time frame: Week 0 to Week 52
Gastrin-17 Antibodies
Time frame: Weeks 0, 6, 12, 24, 36 and 52
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 27 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing G17DT and Gemcitabine 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 8 inclusion and 6 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 27 Jun 2017. 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. 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: Baseline (Week 0) up to Week 52 or death.). 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 27 Jun 2017; AzTrials last refreshed its copy on 2 Nov 2026.