Trial Outcomes & Findings for YF476 and Type II Gastric Carcinoids (NCT NCT02454075)
NCT ID: NCT02454075
Last Updated: 2021-01-29
Results Overview
Regression is defined as a 25% reduction in the size / number of endoscopically evident type II gastric carcinoids. For each participant, three gastric carcinoids were identified and measured at baseline. The same gastric carcinoids were then measured at the Week 12 visit and the percentage difference in size from baseline calculated. The mean percentage change of the three gastric carcinoids per participant is recorded.
TERMINATED
PHASE2
3 participants
Week 12 visit
2021-01-29
Participant Flow
Participant milestones
| Measure |
Eligible Patients
Patients received 100 mg YF476 orally once daily for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
YF476 and Type II Gastric Carcinoids
Baseline characteristics by cohort
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
|
Serum gastrin
Patient 01
|
587 pg/mL
n=5 Participants
|
|
Serum gastrin
Patient 02
|
11348 pg/mL
n=5 Participants
|
|
Serum gastrin
Patient 03
|
1393 pg/mL
n=5 Participants
|
|
Serum chromagraninA (CgA)
Patient 01
|
3410 ng/mL
n=5 Participants
|
|
Serum chromagraninA (CgA)
Patient 02
|
11200 ng/mL
n=5 Participants
|
|
Serum chromagraninA (CgA)
Patient 03
|
2430 ng/mL
n=5 Participants
|
|
Size of gastric carcinoids
Patient 01
|
54.79 mm^2
n=5 Participants
|
|
Size of gastric carcinoids
Patient 02
|
70.20 mm^2
n=5 Participants
|
|
Size of gastric carcinoids
Patient 03
|
24.77 mm^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 visitPopulation: The mean percentage decrease in three gastric carcinoids (measured at Week 12 visit) compared with baseline.
Regression is defined as a 25% reduction in the size / number of endoscopically evident type II gastric carcinoids. For each participant, three gastric carcinoids were identified and measured at baseline. The same gastric carcinoids were then measured at the Week 12 visit and the percentage difference in size from baseline calculated. The mean percentage change of the three gastric carcinoids per participant is recorded.
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Regression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy
Patient 01, Week 12 visit
|
23.7 percentage decrease in carcinoid size
Standard Deviation 6.23
|
|
Regression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy
Patient 02, Week 12 visit
|
8.6 percentage decrease in carcinoid size
Standard Deviation 26.96
|
|
Regression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy
Patient 03, Week 12 visit
|
10.8 percentage decrease in carcinoid size
Standard Deviation 24.44
|
PRIMARY outcome
Timeframe: Week 12 visitPopulation: Due to the early termination of the study, the data for this outcome measure were not collected.
A reduction of 25% in the gastric ECL cell density.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12 visitPopulation: Due to the early termination of the study, the data for this outcome measure were not collected.
Reduction in the histological grade of the carcinoids/hyperplasia when compared to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)Population: The CgA data is provided for each participant at each visit
The level of a key biomarker chromogranin A (CgA) that is circulating in the blood was measured.
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 01, Week 6 visit
|
2600 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 01, Week 12 visit
|
2700 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 01, Follow-up
|
12300 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 02, Week 6 visit
|
11950 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 02, Week 12 visit
|
15350 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 02, Follow up
|
24100 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 03, Week 6 visit
|
213 ng/mL
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 03, Week 12 visit
|
NA ng/mL
Sample taken but source documentation not provided
|
|
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
Patient 03, Follow-up
|
NA ng/mL
Sample taken but source documentation not provided
|
SECONDARY outcome
Timeframe: Week 2 visit (baseline) and Week 6 visitPopulation: Patients had the volume of gastric aspirate measured at Week 2 and Week 6 visit, by either nasogastric tube (NGT; Patient 01 and Patient 02) or endoscopic gastric analysis (EGA; Patient 03). Data is provided for each visit and participant.
Assessed by changes in drug-controlled gastric acid analysis. A nasogastric tube (NGT) was placed through one nare and into the stomach. Gastric secretions were suctioned and discarded at T = 0 and then aspirated for 1 h in 15 min increments to measure the control acid output. Patients who could not tolerate NGT placement had endoscopic gastric analysis (EGA) performed during upper endoscopy. During EGA, a single 10 - 15 min collection was aspirated under direct visualization. Patients 01 and 02 had acid measured via NGT, whereas Patient 03 had acid measured via EGA. At the Week 2 visit, the baseline acid control was measured. At the Week 6 visit, the acid control was measured after a dose of netazepide. Results are provided for three acid control measures: 1. Volume of aspirate (mL) 2. Acid in aspirate (mEq) 3. Acid output (mEq)
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 15 - 30 min
|
5 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 45 - 60 min
|
25 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 0 - 15 min
|
30 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 15 - 30 min
|
50 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 30 - 45 min
|
10 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 45 - 60 min
|
10 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 60 - 75 min
|
49 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 03, Week 2 visit, Day 1, 0 - 15 min
|
15 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 03, Week 6 visit, Day 1, 0 - 15 min
|
17 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 0 - 15 min
|
12 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 15 - 30 min
|
10 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 30 - 45 min
|
4 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 45 - 60 min
|
15 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 0 - 15 min
|
5 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 15 - 30 min
|
7 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 30 - 45 min
|
17 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 45 - 60 min
|
7 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 0 - 15 min
|
10 mL
|
|
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 30 - 45 min
|
40 mL
|
SECONDARY outcome
Timeframe: Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)Population: Data was not collect due to early termination of the study.
Assessed by quantitative PCR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)Population: For each patient, the total score on the GERD-HRQL assessment questionnaire at each visit was summed and reported. Data is provided for each visit and participant.
Assessed by the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) instrument. Patients assessed a total of 10 symptoms on a scale of 0-5 where: 0 = no symptoms; 1 = symptoms noticeable, but not bothersome; 2 = symptoms noticeable and bothersome, but not every day; 3 = symptoms bothersome everyday; 4 = symptoms affect daily activities; and 5 = symptoms are incapacitating (unable to do daily activities). The total score was summed and reported. The maximum obtainable total score was 50 and minimum obtainable total score was 0, with higher scores indicating a worse outcome and lower scores indicating a better outcome.
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 1, Week 2 visit
|
3 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 1, Week 6 visit
|
3 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 1, Week 12 visit
|
2 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 1, Follow up visit
|
4 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 2, Week 2 visit
|
0 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 2, Week 6 visit
|
26 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 2, Week 12 visit
|
10 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 2, Follow up visit
|
19 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 3, Week 2 visit
|
0 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 3, Week 6 visit
|
0 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 3, Week 12 visit
|
0 score on a scale
|
|
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
Patient 3, Follow up visit
|
0 score on a scale
|
SECONDARY outcome
Timeframe: Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)Assessed by monitoring adverse events reported by patients
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Safety and Tolerability
Week 2 visit: number of treatment related adverse events
|
0 adverse events
|
|
Safety and Tolerability
Week 6 visit: number of treatment related adverse events
|
0 adverse events
|
|
Safety and Tolerability
Week 12 visit: number of treatment related adverse events
|
0 adverse events
|
|
Safety and Tolerability
Follow up visit: number of treatment related adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)Population: Data is provided for each visit of each patient. Follow up data is missing for Patient 03 (samples were taken but results not provided).
The level of gastrin biomarkers circulating in the blood was measured.
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Circulating Plasma Concentration of Gastrin
Patient 01, Week 6 visit
|
509 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 01, Week 12 visit
|
355 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 01, Follow-up
|
1105 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 02, Week 6 visit
|
13049 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 02, Week 12 visit
|
12846 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 02, Follow-up
|
14113 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 03, Week 6
|
706 pg/mL
|
|
Circulating Plasma Concentration of Gastrin
Patient 03, Week 12
|
718 pg/mL
|
SECONDARY outcome
Timeframe: Week 2 visit (baseline) and Week 6 visitPopulation: Patients had the acid content in gastric aspirate measured at Week 2 and Week 6 visit, by either nasogastric tube (NGT; Patient 01 and Patient 02) or endoscopic gastric analysis (EGA; Patient 03). Data is provided for each visit and participant.
Assessed by changes in drug-controlled gastric acid analysis. A nasogastric tube (NGT) was placed through one nare and into the stomach. Gastric secretions were suctioned and discarded at T = 0 and then aspirated for 1 h in 15 min increments to measure the control acid output. Patients who could not tolerate NGT placement had endoscopic gastric analysis (EGA) performed during upper endoscopy. During EGA, a single 10 - 15 min collection was aspirated under direct visualization. Patients 01 and 02 had acid measured via NGT, whereas Patient 03 had acid measured via EGA. At the Week 2 visit, the baseline acid control was measured. At the Week 6 visit, the acid control was measured after a dose of netazepide. Results are provided for three acid control measures: 1. Volume of aspirate (mL) 2. Acid in aspirate (mEq) 3. Acid output (mEq)
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 15 - 30 min
|
4.9 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 30 - 45 min
|
5.1 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 45 - 60 min
|
4.9 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 30 - 45 min
|
6.6 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 0 - 15 min
|
6.7 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 15 - 30 min
|
7.4 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 30 - 45 min
|
7.0 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 2 visit, Day 1, 45 - 60 min
|
7.6 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 0 - 15 min
|
1.2 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 15 - 30 min
|
1.2 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 30 - 45 min
|
1.2 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 45 - 60 min
|
1.2 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 02, Week 6 visit, Day 1, 60 - 75 min
|
1.2 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 03, Week 2 visit, Day 1, 0 - 15 min
|
4.9 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 03, Week 6 visit, Day 1, 0 - 15 min
|
1.1 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 2 visit, Day 1, 0 - 15 min
|
5.6 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 0 - 15 min
|
6.9 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 15 - 30 min
|
6.5 mEq
|
|
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
Patient 01, Week 6 visit, Day 1, 45 - 60 min
|
6.7 mEq
|
SECONDARY outcome
Timeframe: Week 2 visit (baseline) and Week 6 visitPopulation: Patients had acid output measured at Week 2 and Week 6 visit, by either nasogastric tube (NGT; Patient 01 and Patient 02) or endoscopic gastric analysis (EGA; Patient 03). Data is provided for each visit and participant.
Assessed by changes in drug-controlled gastric acid analysis. A nasogastric tube (NGT) was placed through one nare and into the stomach. Gastric secretions were suctioned and discarded at T = 0 and then aspirated for 1 h in 15 min increments to measure the control acid output. Patients who could not tolerate NGT placement had endoscopic gastric analysis (EGA) performed during upper endoscopy. During EGA, a single 10 - 15 min collection was aspirated under direct visualization. Patients 01 and 02 had acid measured via NGT, whereas Patient 03 had acid measured via EGA. At the Week 2 visit, the baseline acid control was measured. At the Week 6 visit, the acid control was measured after a dose of netazepide. Results are provided for three acid control measures: 1. Volume of aspirate (mL) 2. Acid in aspirate (mEq) 3. Acid output (mEq)
Outcome measures
| Measure |
Eligible Patients
n=3 Participants
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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 2 visit, Day 1, 0 - 15 min
|
0.1 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 2 visit, Day 1, 15 - 30 min
|
0 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 2 visit, Day 1, 30 - 45 min
|
0 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 2 visit, Day 1, 45 - 60 min
|
0.2 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 6 visit, Day 1, 15 - 30 min
|
0 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 6 visit, Day 1, 30 - 45 min
|
0 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 6 visit, Day 1, 45 - 60 min
|
0 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 2 visit, Day 1, 0 - 15 min
|
0.2 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 2 visit, Day 1, 15 - 30 min
|
0 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 2 visit, Day 1, 30 - 45 min
|
0.7 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 2 visit, Day 1, 45 - 60 min
|
0.4 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 6 visit, Day 1, 0 - 15 min
|
1.8 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 6 visit, Day 1, 15 - 30 min
|
4.1 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 6 visit, Day 1, 30 - 45 min
|
1.2 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 6 visit, Day 1, 45 - 60 min
|
0.7 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 02, Week 6 visit, Day 1, 60 - 75 min
|
1.6 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 03, Week 2 visit, Day 1, 0 - 15 min
|
1.2 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 03, Week 6 visit, Day 1, 0 - 15 min
|
4.6 mEq
|
|
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
Patient 01, Week 6 visit, Day 1, 0 - 15 min
|
0 mEq
|
Adverse Events
Eligible Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eligible Patients
n=3 participants at risk
The dose will be an oral dose of 100 mg YF476 once daily. for 12 weeks. 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.
YF476: Gastrin receptor antagonist
|
|---|---|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • 12 weeks
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
33.3%
1/3 • 12 weeks
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • 12 weeks
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 2 • 12 weeks
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2 • 12 weeks
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment.
|
|
Infections and infestations
Upper respiratory tract infections
|
33.3%
1/3 • Number of events 1 • 12 weeks
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place