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TerminatedNCT02454075Updated Jan 29, 2021Results posted

YF476 and Type II Gastric Carcinoids

A Phase 2 interventional study of YF476 in Zollinger-Ellison Syndrome, sponsored by Trio Medicines Ltd.. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Trio Medicines Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
Poor recruitment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Apr 2011, registered May 2015).
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Zollinger-Ellison Syndrome

Keywords

  • YF476
  • netazepide
  • gastric carcinoids
  • Zollinger-Ellison syndrome
03

In context

Carcinoid Tumor

152 studies on the registry are indexed under Carcinoid Tumor; 16 are open to participants now.

This study's enrollment of 3 is below the median of 36 across 106 interventional studies indexed under Carcinoid Tumor.

Browse Carcinoid Tumor studies →

Lead sponsor

Trio Medicines Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    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.

    Drug: YF476

Interventions

  • DrugYF476

    Gastrin receptor antagonist

    Also known as: Netazepide

06

What researchers measure

Primary outcomes

  1. Regression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy

    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.

    Time frame: Week 12 visit

  2. A Reduction of 25% in the Gastric ECL Cell Density.

    A reduction of 25% in the gastric ECL cell density.

    Time frame: Week 12 visit

Secondary outcomes

  1. Improvement in Histological Grade of Gastric Carcinoids/ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy

    Reduction in the histological grade of the carcinoids/hyperplasia when compared to baseline.

    Time frame: Week 12 visit

  2. Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples

    The level of a key biomarker chromogranin A (CgA) that is circulating in the blood was measured.

    Time frame: Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)

  3. Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate

    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)

    Time frame: Week 2 visit (baseline) and Week 6 visit

  4. Decrease in ECL Cell-specific Products Assessed by Quantitative PCR

    Assessed by quantitative PCR.

    Time frame: Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)

  5. Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument

    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.

    Time frame: Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)

  6. Safety and Tolerability

    Assessed by monitoring adverse events reported by patients

    Time frame: Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)

  7. Circulating Plasma Concentration of Gastrin

    The level of gastrin biomarkers circulating in the blood was measured.

    Time frame: Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)

  8. Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate

    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)

    Time frame: Week 2 visit (baseline) and Week 6 visit

  9. Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output

    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)

    Time frame: Week 2 visit (baseline) and Week 6 visit

07

Results

Posted Jan 29, 2021

Participant flow

Participant flow — Overall Study
MilestoneEligible Patients
Started3
Completed3
Not completed0

Outcome measures

PrimaryRegression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy

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.

Time frame:
Week 12 visit
Reported as:
Mean · percentage decrease in carcinoid size
Regression of Gastric Carcinoids and/or ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy
percentage decrease in carcinoid sizeEligible Patients
Patient 01, Week 12 visit23.7 ± 6.23
Patient 02, Week 12 visit8.6 ± 26.96
Patient 03, Week 12 visit10.8 ± 24.44
PrimaryA Reduction of 25% in the Gastric ECL Cell Density.

A reduction of 25% in the gastric ECL cell density.

Time frame:
Week 12 visit

No measurements were reported for this outcome.

SecondaryImprovement in Histological Grade of Gastric Carcinoids/ECL Cell Hyperplasia Defined by Physical Measurements Taken During Endoscopy

Reduction in the histological grade of the carcinoids/hyperplasia when compared to baseline.

Time frame:
Week 12 visit

No measurements were reported for this outcome.

SecondaryLevel of Chromogranin A (CgA) Biomarkers Measured in Blood Samples

The level of a key biomarker chromogranin A (CgA) that is circulating in the blood was measured.

Time frame:
Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)
Reported as:
Number · ng/mL
Level of Chromogranin A (CgA) Biomarkers Measured in Blood Samples
ng/mLEligible Patients
Patient 01, Week 6 visit2600
Patient 01, Week 12 visit2700
Patient 01, Follow-up12300
Patient 02, Week 6 visit11950
Patient 02, Week 12 visit15350
Patient 02, Follow up24100
Patient 03, Week 6 visit213
Patient 03, Week 12 visitNA
Patient 03, Follow-upNA
SecondaryAcid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate

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)

Time frame:
Week 2 visit (baseline) and Week 6 visit
Reported as:
Number · mL
Acid Control Study 1, Control of Gastric Acid Secretion Assessed by Changes in Drug-controlled Gastric Acid Analysis, Volume of Gastric Aspirate
mLEligible Patients
Patient 01, Week 2 visit, Day 1, 0 - 15 min12
Patient 01, Week 2 visit, Day 1, 15 - 30 min10
Patient 01, Week 2 visit, Day 1, 30 - 45 min4
Patient 01, Week 2 visit, Day 1, 45 - 60 min15
Patient 01, Week 6 visit, Day 1, 0 - 15 min5
Patient 01, Week 6 visit, Day 1, 15 - 30 min7
Patient 01, Week 6 visit, Day 1, 30 - 45 min17
Patient 01, Week 6 visit, Day 1, 45 - 60 min7
Patient 02, Week 2 visit, Day 1, 0 - 15 min10
Patient 02, Week 2 visit, Day 1, 15 - 30 min5
Patient 02, Week 2 visit, Day 1, 30 - 45 min40
Patient 02, Week 2 visit, Day 1, 45 - 60 min25
Patient 02, Week 6 visit, Day 1, 0 - 15 min30
Patient 02, Week 6 visit, Day 1, 15 - 30 min50
Patient 02, Week 6 visit, Day 1, 30 - 45 min10
Patient 02, Week 6 visit, Day 1, 45 - 60 min10
Patient 02, Week 6 visit, Day 1, 60 - 75 min49
Patient 03, Week 2 visit, Day 1, 0 - 15 min15
Patient 03, Week 6 visit, Day 1, 0 - 15 min17
SecondaryDecrease in ECL Cell-specific Products Assessed by Quantitative PCR

Assessed by quantitative PCR.

Time frame:
Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)

No measurements were reported for this outcome.

SecondaryImprovement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument

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.

Time frame:
Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)
Reported as:
Number · score on a scale
Improvement in Reflux/Dyspepsia Symptoms Using the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Instrument
score on a scaleEligible Patients
Patient 1, Week 2 visit3
Patient 1, Week 6 visit3
Patient 1, Week 12 visit2
Patient 1, Follow up visit4
Patient 2, Week 2 visit0
Patient 2, Week 6 visit26
Patient 2, Week 12 visit10
Patient 2, Follow up visit19
Patient 3, Week 2 visit0
Patient 3, Week 6 visit0
Patient 3, Week 12 visit0
Patient 3, Follow up visit0
SecondarySafety and Tolerability

Assessed by monitoring adverse events reported by patients

Time frame:
Week 2 visit (baseline), Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)
Reported as:
Number · adverse events
Safety and Tolerability
adverse eventsEligible Patients
Week 2 visit: number of treatment related adverse events0
Week 6 visit: number of treatment related adverse events0
Week 12 visit: number of treatment related adverse events0
Follow up visit: number of treatment related adverse events0
SecondaryCirculating Plasma Concentration of Gastrin

The level of gastrin biomarkers circulating in the blood was measured.

Time frame:
Week 6 visit, Week 12 visit, Follow-up (12 weeks after stopping YF476 treatment)
Reported as:
Number · pg/mL
Circulating Plasma Concentration of Gastrin
pg/mLEligible Patients
Patient 01, Week 6 visit509
Patient 01, Week 12 visit355
Patient 01, Follow-up1105
Patient 02, Week 6 visit13049
Patient 02, Week 12 visit12846
Patient 02, Follow-up14113
Patient 03, Week 6706
Patient 03, Week 12718
SecondaryAcid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate

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)

Time frame:
Week 2 visit (baseline) and Week 6 visit
Reported as:
Number · mEq
Acid Control Study 2, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Content in Gastric Aspirate
mEqEligible Patients
Patient 01, Week 2 visit, Day 1, 0 - 15 min5.6
Patient 01, Week 2 visit, Day 1, 15 - 30 min4.9
Patient 01, Week 2 visit, Day 1, 30 - 45 min5.1
Patient 01, Week 2 visit, Day 1, 45 - 60 min4.9
Patient 01, Week 6 visit, Day 1, 0 - 15 min6.9
Patient 01, Week 6 visit, Day 1, 15 - 30 min6.5
Patient 01, Week 6 visit, Day 1, 30 - 45 min6.6
Patient 01, Week 6 visit, Day 1, 45 - 60 min6.7
Patient 02, Week 2 visit, Day 1, 0 - 15 min6.7
Patient 02, Week 2 visit, Day 1, 15 - 30 min7.4
Patient 02, Week 2 visit, Day 1, 30 - 45 min7.0
Patient 02, Week 2 visit, Day 1, 45 - 60 min7.6
Patient 02, Week 6 visit, Day 1, 0 - 15 min1.2
Patient 02, Week 6 visit, Day 1, 15 - 30 min1.2
Patient 02, Week 6 visit, Day 1, 30 - 45 min1.2
Patient 02, Week 6 visit, Day 1, 45 - 60 min1.2
Patient 02, Week 6 visit, Day 1, 60 - 75 min1.2
Patient 03, Week 2 visit, Day 1, 0 - 15 min4.9
Patient 03, Week 6 visit, Day 1, 0 - 15 min1.1
SecondaryAcid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output

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)

Time frame:
Week 2 visit (baseline) and Week 6 visit
Reported as:
Number · mEq
Acid Control Study 3, Control of Gastric Acid Secretion Assess by Changes in Drug-controlled Gastric Acid Analysis: Acid Output
mEqEligible Patients
Patient 01, Week 2 visit, Day 1, 0 - 15 min0.1
Patient 01, Week 2 visit, Day 1, 15 - 30 min0
Patient 01, Week 2 visit, Day 1, 30 - 45 min0
Patient 01, Week 2 visit, Day 1, 45 - 60 min0.2
Patient 01, Week 6 visit, Day 1, 0 - 15 min0
Patient 01, Week 6 visit, Day 1, 15 - 30 min0
Patient 01, Week 6 visit, Day 1, 30 - 45 min0
Patient 01, Week 6 visit, Day 1, 45 - 60 min0
Patient 02, Week 2 visit, Day 1, 0 - 15 min0.2
Patient 02, Week 2 visit, Day 1, 15 - 30 min0
Patient 02, Week 2 visit, Day 1, 30 - 45 min0.7
Patient 02, Week 2 visit, Day 1, 45 - 60 min0.4
Patient 02, Week 6 visit, Day 1, 0 - 15 min1.8
Patient 02, Week 6 visit, Day 1, 15 - 30 min4.1
Patient 02, Week 6 visit, Day 1, 30 - 45 min1.2
Patient 02, Week 6 visit, Day 1, 45 - 60 min0.7
Patient 02, Week 6 visit, Day 1, 60 - 75 min1.6
Patient 03, Week 2 visit, Day 1, 0 - 15 min1.2
Patient 03, Week 6 visit, Day 1, 0 - 15 min4.6

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eligible Patients0/3 (0%)0/3 (0%)3/3 (100%)
Most frequent other events
Most frequent other events
EventEligible Patients
ToothacheGastrointestinal disorders1/3
Stomach painGastrointestinal disorders1/3
DiarrhoeaGastrointestinal disorders1/3
HypertensionVascular disorders1/3
Abdominal painGastrointestinal disorders1/3
Upper respiratory tract infectionsInfections and infestations1/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Eligible Patients
<=18 years0
Between 18 and 65 years3
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Eligible Patients
Female0
Male3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Eligible Patients
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White3
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Eligible Patients
United States3
Serum gastrin
Serum gastrin(pg/mL)Eligible Patients
Patient 01587
Patient 0211348
Patient 031393
Serum chromagraninA (CgA)
Serum chromagraninA (CgA)(ng/mL)Eligible Patients
Patient 013410
Patient 0211200
Patient 032430
Size of gastric carcinoids
Size of gastric carcinoids(mm^2)Eligible Patients
Patient 0154.79 (29.68 to 74.92)
Patient 0270.20 (37.09 to 131.21)
Patient 0324.77 (12.00 to 34.95)
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02454075
Lead sponsor
Trio Medicines Ltd.
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
May 27, 2015
Start date
Apr 11, 2011
Primary completion
Jun 22, 2012
Completion
Jun 22, 2012
Results posted
Jan 29, 2021
Last update
Jan 29, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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