Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients

Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients - IMPROVE-NET trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004091-35-NL

Enrollment

Registered

2019-03-28

Start date

2019-04-19

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine tumors MedDRA version: 20.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10077559 Term: Gastroenteropancreatic neuroendocrine tumour disease System Or

Interventions

Trade Name: Hydralazine Product Name: Hydralazine Product Code: RVG 50725 Pharmaceutical Form: Tablet Trade Name: Valproate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age =18 years • Inoperable or metastasized neuroendocrine tumor with well-differentiated histology (grade 1 or 2) • SSTR2 negativity on 68Ga DOTATATE PET scan, defined as tumor uptake on 68Ga-DOTATATE PET CT below that of the liver Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Hypotension, defined as systolic blood pressure 3 times upper normal range • Epilepsy • Known allergies / intolerances to valproic acid or hydralazine • Existing drug treatment which cannot be stopped and interacts or interferes with study drugs • Inability to provide informed consent • End of life care

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of the planned trial is to show, that combined treatment with the epigenetic drugs valproic acid and hydralazine will lead to an increase in SSTR2 expression levels in patients with metastasized Grade 1 or 2 NETs with low uptake on 68Ga-DOTATATE-PET CT.; Secondary Objective: • Safety monitoring: adverse events • Circulation drug levels of valproic acid • Dosimetric evaluation of intra- and intertumoral SSTR2 expression • Leucocyte methylation analysis ;Primary end point(s): The percentage of patients that will have an uptake of 68Ga-DOTATATE in the tumor equal to or above that of the liver. ;Timepoint(s) of evaluation of this end point: After 14 days of treatment	—

Measure

Time frame

Main Objective: The primary aim of the planned trial is to show, that combined treatment with the epigenetic drugs valproic acid and hydralazine will lead to an increase in SSTR2 expression levels in patients with metastasized Grade 1 or 2 NETs with low uptake on 68Ga-DOTATATE-PET CT.; Secondary Objective: • Safety monitoring: adverse events • Circulation drug levels of valproic acid • Dosimetric evaluation of intra- and intertumoral SSTR2 expression • Leucocyte methylation analysis ;Primary end point(s): The percentage of patients that will have an uptake of 68Ga-DOTATATE in the tumor equal to or above that of the liver. ;Timepoint(s) of evaluation of this end point: After 14 days of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Safety monitoring, circulating drug levels, dosimetric evaluations and leucocyte methylation analysis.;Timepoint(s) of evaluation of this end point: After 7 and 14 days of treatment	—

Countries

Netherlands

Contacts

Public ContactJohannes Hofland

Erasmus University Medical Center

j.hofland@erasmusmc.nl+31107040446

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026