Colorectal CancerPhase 2CC4NCT02223078
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
A Phase 2 study testing G17DT in people with Colorectal Cancer, run by Cancer Advances Inc. at 1 site in United Kingdom.
Trial summary
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- G17DT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2000to Nov 2001
- 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 histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
- Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
- Proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
- Male or female patients from 18 to 65 years of age.
- Patients with a life expectancy of over three months.
- World Health Organisation (WHO) Performance Status of 0 to 1.
- Written informed consent given.
Who cannot join
- Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
- Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
- History of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix.
- Previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
- Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
- Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
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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 the study.
- Previous G 17DT treatment.
- Haematological indicators:
- Haemoglobin <10.0 g/dL White blood cell count <4.0 x 109/L Platelets < 100 x 1 09/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Two Centre Study to Determine the Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.
- Conditions
- Colorectal Cancer
- Being tested
- G17DT, Placebo Comparator
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G17DTBiological
Placebo ComparatorBiological
| Study group | Role | What they receive |
|---|---|---|
| G17DT | Experimental | Three 250 µg injections over a six week period (weeks 0,2 and 6) Receives: Biological: G17DT |
| Placebo | Placebo comparator | Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6) Receives: Biological: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Levels
Assess effects of gastrin-17 antibodies in response to G17DT immunization.
Measured: 12 weeks
Secondary outcomes (2)
pharmacodynamic
measure production of gastrin-17 antibodies.
Measured: 12 weeks
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: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2000
- Primary completionAug 2001
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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, Care provider, Investigator
Sponsor and investigators
- Lead sponsor
- Cancer Advances Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223078
- Sponsor's protocol ID
- CC4
- Acronym
- CC4
- Status last verified
- Aug 2014
- First submitted
- 2 Jul 2014
- Last updated
- 20 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Two Centre Study to Determine the Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT02223078
- Acronym / sponsor ID
- CC4 / CC4
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Aug 2001 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 22 Aug 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.
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G17DT | Experimental | Biological: G17DTThree 250 µg injections over a six week period (weeks 0,2 and 6) |
| Placebo | Placebo comparator | Biological: Placebo ComparatorThree 250 µg injections of a placebo over a six week period (weeks 0,2 and 6) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
- Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
- Proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
- Male or female patients from 18 to 65 years of age.
- Patients with a life expectancy of over three months.
Key exclusion criteria (10 listed)
- Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
- Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
- History of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix.
- Previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
- Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
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 | Biological | G17DT |
| Placebo Comparator | Biological | Placebo |
Primary outcome
Antibody Levels
Time frame: 12 weeks
Assess effects of gastrin-17 antibodies in response to G17DT immunization.
2 secondary outcomes
pharmacodynamic
Time frame: 12 weeks
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 12 weeks
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 20 Jun 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G17DT in people with Colorectal Cancer, run by Cancer Advances Inc. at 1 site in United Kingdom.
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 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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 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?
Antibody Levels (time frame: 12 weeks). 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 20 Jun 2017.