YF476 and Type II Gastric Carcinoids

NCT ID: NCT02454075

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-11
• Study Completion Date: 2012-06-22

Brief 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.

Conditions

Zollinger-Ellison Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eligible patients

The dose will be 100 mg YF476 once daily. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.

Group Type: EXPERIMENTAL

YF476

Intervention Type: DRUG

Gastrin receptor antagonist

Interventions

YF476

Gastrin receptor antagonist

Intervention Type: DRUG

Other Intervention Names

Netazepide

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients with serum gastrin >250 pg/mL.

3. Hepatic function: AST and ALT ≤2.0 x ULN; total bilirubin ≤1.0 x ULN.

4. Renal function: serum creatinine <1.0 x ULN.

5. Haematologic function: Hb ≥10.0 g/dL; WBC ≥3.5 x 10e9 /L; ANC ≥1.5 x 10e9 /L; platelets ≥100 x 10e9 /L.

6. Coagulation parameters: INR or PT ≤1.0 x ULN; PTT ≤1.0 x ULN.

7. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.

8. Willingness to give fully-informed, written consent.

Exclusion Criteria

1. Patients under 18 years.

2. Women who are pregnant, lactating or using a steroid contraceptive.

3. Prior gastric resection or bypass.

4. Planned gastrinoma resection during the study period.

5. Patients on somatostatin analogues, except for those on therapy for >6 months with stable or worsening carcinoids.

6. Inability to tolerate endoscopy, or refusal of endoscopy.

7. 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.

8. Certain medicines and herbal remedies taken during the 7 days before visit 2.

9. Participation in a trial of an IMP within the previous 28 days.

10. Presence of drug or alcohol abuse.

11. History or baseline findings of:

• type 1 diabetes mellitus;
• pancreatitis (baseline amylase and/or >2.0 x ULN);
• hepatitis B, hepatitis C or HIV;
• malabsorption syndrome or inability to swallow or retain oral medicine;
• major surgery <28 days prior to enrolment;
• ECOG performance status >2; or
• another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in-situ.
• Also, any clinically significant and uncontrolled major morbidity including but not limited to; serious cardiac disease (unstable angina, s/p myocardial infarction <1 month); respiratory disease (advanced COPD or pulmonary fibrosis); uncontrolled hypertension; or active systemic infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Trio Medicines Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NCT01322542

Identifier Type: -

Identifier Source: nct_alias

11-DK-0114

Identifier Type: OTHER

Identifier Source: secondary_id

T-010

Identifier Type: -

Identifier Source: org_study_id