Colorectal CancerPhase 2CC1A&BNCT02181465
Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.
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 81 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- G17DT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 1993to May 1994
- 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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified adenocarcinoma of the colon or rectum
- Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
- measurable/ evaluable lesions
- Life expectancy > 3 months
- Karnofsky index > 50% or WHO performance rating of 0-2
- Biochemical markers:
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- renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
- liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)
- Haematological status:
- haemoglobin, 11 g/ dl
- WBC, 4 X 109/1
- platelets, 100 x 109/l
- Written consent
Who cannot join
- Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
- H 2 receptor antagonist or proton pump inhibitor therapy
- Previous gastric surgery (including vagotomy)
- Active uncontrolled infection
- Autoimmune disorders
- Anticancer treatment within the last three months unless progression of the disease occurred in the interim
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- Women of child-bearing age
- Patient is a poor medical risk because of non-malignant systemic disease
- Previous radiotherapy to all measurable or evaluable lesions.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital, Queen's Medical Centre
Nottingham, Nottinghamshire
About this study
Official title: Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period Receives: Biological: G17DT |
| Group 2 | Experimental | Three injections of G17DT with option of one booster after 16 weeks Receives: Biological: G17DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse effects
Measured: Up to week 16
Secondary outcomes (1)
Measure serum anti gastrin-17 antibodies to determine immunological response to medication
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 posted4 Jul 2014 (estimated)
- Study startOct 1993
- Primary completionMay 1994
- Study completionMay 1994
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT02181465
- Sponsor's protocol ID
- CC1A&B
- Acronym
- CC1A&B
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 4 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT02181465
- Acronym / sponsor ID
- CC1A&B / CC1A&B
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 1993
- Primary completion
- May 1994 (actual)
- Study completion
- May 1994 (actual)
- First posted
- 4 Jul 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: G17DTOne injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period |
| Group 2 | Experimental | Biological: G17DTThree injections of G17DT with option of one booster after 16 weeks |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically verified adenocarcinoma of the colon or rectum
- Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
- measurable/ evaluable lesions
- Life expectancy > 3 months
- Karnofsky index > 50% or WHO performance rating of 0-2
Key exclusion criteria (9 listed)
- Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
- H 2 receptor antagonist or proton pump inhibitor therapy
- Previous gastric surgery (including vagotomy)
- Active uncontrolled infection
- Autoimmune disorders
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 | Group 1, Group 2 |
Primary outcome
Number of participants with adverse effects
Time frame: Up to week 16
1 secondary outcome
Measure serum anti gastrin-17 antibodies to determine immunological response to medication
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 4 Jul 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.
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 13 inclusion and 9 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 4 Jul 2014. 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. 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?
Number of participants with adverse effects (time frame: Up to week 16). 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 4 Jul 2014.