A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer

A Phase 2 study testing G17DT in people with Colorectal Cancer, run by Cancer Advances Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer. Read more about this study

Who is it for?: Ages 18 years and older, men only
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: 5 participants
Where: No sites listed yet
Study dates: May 1994to Oct 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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
Life expectancy greater than 3 months.
Karnofsky Index Score greater than or equal to 50%.
Written informed consent obtained.

Who cannot join

Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
Acute intercurrent illness.
Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
Patients who had received any other anticancer therapy within 3 months.
Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
Patients immunologically compromised including those on corticosteroid therapy.

Show all 10Show fewer

Women of child-bearing age.
Positive immediate hypersensitivity reaction to skin testing with study medication.
Patients unable to complete the diary book
Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10^9/L Platelet count less than 100 x 10^9/L

About this study

Official title: Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.

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
Also called Polyclonal Antibody Stimulator

Study groups in NCT02228785
Study group	Role	What they receive
100µg dose of G17DT	Experimental	Patients in this arm received a 100µg dose of G17DT via intramuscular injection. Receives: Biological: G17DT
200µg dose of G17DT	Experimental	Patients in this arm received a 200 µg dose of G17DT via intramuscular injection. Receives: Biological: G17DT
500µg dose of G17DT	Experimental	Patients in this arm received a 500µg dose of G17DT via intramuscular injection. Receives: Biological: G17DT

What is being measured

The primary outcome is the main question the study is designed to answer.

Injection Site Reaction
An examination was performed to assess injection site tolerability at every posttreatment visit.
Measured: Through Week 12
Antibody Levels
Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.
Measured: Through Week 12

Secondary outcomes (1)

Intra-gastric pH
Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
Measured: Through Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 1994Oct 1994

First posted29 Aug 2014 (estimated)
Study startMay 1994
Primary completionOct 1994

Why it stopped: Poor local tolerance to injection.

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
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02228785
Sponsor's protocol ID: CC1C
Acronym: CC1C
Status last verified: Aug 2014
First submitted: 27 Aug 2014
Last updated: 29 Aug 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
ClinicalTrials.gov ID: NCT02228785
Acronym / sponsor ID: CC1C / CC1C
Conditions: Colorectal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor local tolerance to injection.
Enrolment: 5 participants (actual)
Lead sponsor: Cancer Advances Inc.Industry (pharma, biotech, devices)
Study start: May 1994
Primary completion: Oct 1994 (actual)
First posted: 29 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.

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
100µg dose of G17DT	Experimental	Biological: G17DTPatients in this arm received a 100µg dose of G17DT via intramuscular injection.
200µg dose of G17DT	Experimental	Biological: G17DTPatients in this arm received a 200 µg dose of G17DT via intramuscular injection.
500µg dose of G17DT	Experimental	Biological: G17DTPatients in this arm received a 500µg dose of G17DT via intramuscular injection.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
Life expectancy greater than 3 months.
Karnofsky Index Score greater than or equal to 50%.
Written informed consent obtained.

Key exclusion criteria (10 listed)

Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
Acute intercurrent illness.
Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
Patients who had received any other anticancer therapy within 3 months.
Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.

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	Biological	100µg dose of G17DT, 200µg dose of G17DT, 500µg dose of G17DT

Primary outcome

Injection Site Reaction
Time frame: Through Week 12
An examination was performed to assess injection site tolerability at every posttreatment visit.
Antibody Levels
Time frame: Through Week 12
Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.

1 secondary outcome

Intra-gastric pH
Time frame: Through Week 8

Results and safety

The study was stopped early (reason given: Poor local tolerance to injection.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
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Colorectal Cancer

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.

J D Hardcastle, MChir, FRCP, FRCS principal investigator

University of Nottingham

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..

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 5 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: stopped early, as of the sponsor's last update on 29 Aug 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 was stopped early (reason given: Poor local tolerance to injection.). Results are not available in the source record.

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?

Injection Site Reaction (time frame: Through Week 12). 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?

On the ClinicalTrials.gov record for NCT02228785.

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 29 Aug 2014.