Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.
CC1A&B
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.
1 other identifier
interventional
11
1 country
1
Brief 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 activity of cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 colorectal-cancer
Started Oct 1993
Shorter than P25 for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 1994
CompletedFirst Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 4, 2014
CompletedJuly 4, 2014
July 1, 2014
7 months
July 2, 2014
July 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse effects
Up to week 16
Secondary Outcomes (1)
Measure serum anti gastrin-17 antibodies to determine immunological response to medication
Up to week 16
Study Arms (2)
Group 1
EXPERIMENTALOne injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period
Group 2
EXPERIMENTALThree injections of G17DT with option of one booster after 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Queen's Medical Centre
Nottingham, Nottinghamshire, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 4, 2014
Study Start
October 1, 1993
Primary Completion
May 1, 1994
Study Completion
May 1, 1994
Last Updated
July 4, 2014
Record last verified: 2014-07