JaundicePhase 2NCT02098239
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
A Phase 2 study testing G17DT in people with Jaundice and Pancreatic Cancer, run by Cancer Advances Inc..
Trial summary
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Jaundice, Pancreatic Cancer
- What is being tested?
- G17DT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to May 2002
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
- If patients were jaundiced, bilirubin had to be >80 μmol/L.
- Male or female patients over 18 years of age.
- World Health Organization (WHO) performance status of 0 to 2.
- Patients with a life expectancy of at least 8 weeks.
- Patients must have given written informed consent.
Who cannot join
- Patients undergoing a potentially curative resection.
- Jaundiced patients with a bilirubin value <80 μmol/L.
- Patients not considered fit for endoscopic or percutaneous biliary stenting.
- Patients receiving any other anti-cancer therapy.
- History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
- Females who were pregnant, planning to become pregnant, or who were lactating.
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- Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
- Previous G17DT treatment.
- Haematological indicators:
- Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.
About this study
Official title: An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
Read the detailed description
Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.
- Conditions
- Jaundice, Pancreatic Cancer
- Being tested
- G17DT
- Medical subject headings
- Jaundice, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G17DTDrug
Also called Polyclonal Antibody Stimulator (PAS)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting. Receives: Drug: G17DT |
| Group B | Active comparator | Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L. Receives: Drug: G17DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic
Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.
Measured: Weeks 0, 1,3,4,6,8,12, 16+
Patient Survival
The vital status of patients was monitored throughout the study and was followed until death or the end of the study.
Measured: Up to week 139
Secondary outcomes (1)
Injection Tolerability
Tolerability was assessed by injection site during first 16 weeks after the first injection.
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startAug 1999
- Primary completionApr 2002
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JaundiceStudies 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT02098239
- Sponsor's protocol ID
- PC2
- Status last verified
- Mar 2014
- First submitted
- 25 Mar 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT02098239
- Acronym / sponsor ID
- PC2
- Conditions
- Jaundice, Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Apr 2002 (actual)
- Study completion
- May 2002
- First posted
- 27 Mar 2014 (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 study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
Detailed description
Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: G17DTJaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting. |
| Group B | Active comparator | Drug: G17DTPatients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
- If patients were jaundiced, bilirubin had to be >80 μmol/L.
- Male or female patients over 18 years of age.
- World Health Organization (WHO) performance status of 0 to 2.
- Patients with a life expectancy of at least 8 weeks.
Key exclusion criteria (10 listed)
- Patients undergoing a potentially curative resection.
- Jaundiced patients with a bilirubin value <80 μmol/L.
- Patients not considered fit for endoscopic or percutaneous biliary stenting.
- Patients receiving any other anti-cancer therapy.
- History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
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: Polyclonal Antibody Stimulator (PAS) | Drug | Group A, Group B |
Primary outcome
Pharmacodynamic
Time frame: Weeks 0, 1,3,4,6,8,12, 16+
Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.
Patient Survival
Time frame: Up to week 139
The vital status of patients was monitored throughout the study and was followed until death or the end of the study.
1 secondary outcome
Injection Tolerability
Time frame: Up to Week 16
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 Mar 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.
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 2 study testing G17DT in people with Jaundice and 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 6 inclusion and 10 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 Mar 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. 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?
Pharmacodynamic (time frame: Weeks 0, 1,3,4,6,8,12, 16+). The study lists 2 primary outcomes in all. 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 Mar 2014.