YF476 and Type II Gastric Carcinoids (NCT02454075) | Clinical Trial Compass
TerminatedPhase 2
YF476 and Type II Gastric Carcinoids
Stopped: Poor recruitment
3 participantsStarted 2011-04-11
Plain-language summary
This study will evaluate whether treatment with YF476 is safe and effective in reducing the size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL cells, in patients with Zollinger-Ellison syndrome.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men; post-menopausal women; pre-menopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophorectomy; or pre-menopausal women using one of the allowed methods of contraception: condom and spermicide or intra-uterine device.
✓. Patients with serum gastrin \>250 pg/mL.
✓. Hepatic function: AST and ALT ≤2.0 x ULN; total bilirubin ≤1.0 x ULN.
✓. Renal function: serum creatinine \<1.0 x ULN.
✓. Haematologic function: Hb ≥10.0 g/dL; WBC ≥3.5 x 10e9 /L; ANC ≥1.5 x 10e9 /L; platelets ≥100 x 10e9 /L.
✓. Coagulation parameters: INR or PT ≤1.0 x ULN; PTT ≤1.0 x ULN.
✓. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
✓. Willingness to give fully-informed, written consent.
Exclusion criteria
✕. Patients under 18 years.
✕. Women who are pregnant, lactating or using a steroid contraceptive.
✕. Prior gastric resection or bypass.
✕. Planned gastrinoma resection during the study period.
✕. Patients on somatostatin analogues, except for those on therapy for \>6 months with stable or worsening carcinoids.
What they're measuring
1
Regression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy
Timeframe: Week 12 visit
2
A Reduction of 25% in the Gastric ECL Cell Density.
✕. Inability to tolerate endoscopy, or refusal of endoscopy.
✕. Physical findings, ECG (especially prolonged QTc interval \>450 msec), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject.
✕. Certain medicines and herbal remedies taken during the 7 days before visit 2.