Status:
TERMINATED
YF476 and Type I Gastric Carcinoids (Norway)
Lead Sponsor:
Trio Medicines Ltd.
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Chronic Atrophic Gastritis
Hypergastrinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to find out if the experimental medicine, YF476, can make gastric carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur mainly in patients w...
Eligibility Criteria
Inclusion
- Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the outpatient clinic of the investigator;
- Men, postmenopausal women, premenopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophorectomy, or premenopausal women using reliable contraception: condom and spermicide or intrauterine device;
- Adults ≥ 18 years;
- Good general health; and
- Able to give fully-informed, written consent.
Exclusion
- Women who are pregnant, lactating or using a steroid contraceptive;
- History of gastric surgery, apart from surgery for gastric carcinoids;
- Evidence of Zollinger-Ellison syndrome;
- Prolonged QTc interval (\>450 msec);
- Certain medicines and herbal remedies taken during the 7 days before visit 1;
- Previous treatment with somatostatin; or
- Participation in other clinical trials of unlicensed medicines within the previous 3 months.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01444014
Start Date
June 1 2011
End Date
May 1 2012
Last Update
May 15 2015
Active Locations (1)
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1
Institutt for kreftforskning og molekylaer medisin
Trondheim, Norway