Safety and tolerability of an injectable diagnostic radiopharmaceutical (68Ga-DOTATOC) in patients with proven gastro-entero-pancreatic neuroendocrine tumors.

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2014-002741-21-GB
• Date of registration: 03/09/2014
• Prospective Registration: Yes
• Primary sponsor: Advanced Accelerator Applications SA
• Public title: Safety and tolerability of an injectable diagnostic radiopharmaceutical (68Ga-DOTATOC) in patients with proven gastro-entero-pancreatic neuroendocrine tumors.
• Scientific title: Safety and tolerability of 68Ga-DOTATOC for injection in patients with proven gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). - 68Ga-DOTATOC in patients with GEP-NETs
• Date of first enrolment: 23/10/2014
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002741-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Clementina Brambati
• Affiliation: Advanced Accelerator Applications

• Name: Clementina Brambati
• Affiliation: Advanced Accelerator Applications

Key inclusion & exclusion criteria

Inclusion criteria:
•Patients with confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) where increased expression of somatostatin receptors is the diagnosis target in case of disease characterization, staging or restaging.
•Biopsy proven Grade I or II GEP-NET, as per WHO classification, confirmed by histology/ immuno-histochemistry.
•Staging assessed by CT/MRI within 3 months prior to enrolment.
•Age = 18 year old.
•ECOG Performance Status = 2.
•Females of childbearing potential must have a negative pregnancy test at screening/baseline.
•Absence of clinically significant ECG abnormalities.
•Ability to understand and sign an informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
•Any patient receiving a treatment with short-acting Octreotide which cannot be interrupted for 24 h before administration of 68Ga-DOTATOC, or any patient receiving a treatment with long-acting SSA which cannot be interrupted for at least 4 weeks before the administration {i.e. 68Ga-DOTATOC administration should not be performed earlier than 4 weeks (+/- 3) days after the last administration of long-lasting SSA}.
•Pregnancy or lactation.
•Known hypersensitivity to the investigational drug or any of its components.
•Patients who have not provided a signed informed consent form to participate in the study, prior to the start of any protocol related activities.
•Patients who, within the last 30 days, have participated in any clinical study of a therapeutic agent which may interfere with the safety or efficacy analysis of the investigational product.
•Any other disease conditions, such as inflammatory or granulomatous diseases, or abnormal physical finding that may interfere with the study objective as judged by the investigator.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with proven gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
MedDRA version: 17.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Kit for the preparation of 68Ga-DOTATOC for injection
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: DOTA0-Tyr3-Octreotide
CAS Number: 204318-14-9
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 36-44

Primary Outcome(s)

Main Objective: To assess the safety and tolerability of a single administration of 2 MBq/kg - but not less than 100 MBq - of 68Ga-DOTATOC in patients suffering from gastro-entero-pancreatic neuroendocrine tumours.

Primary end point(s): The primary outcome is safety and tolerability of a single administration of 68Ga-DOTATOC, assessed by adverse events, physical examination, vital signs, ECG, haematology, biochemistry, and urine tests performed at different time points before and after the study product administration.

Secondary Objective: No secondary objective

Timepoint(s) of evaluation of this end point: Adverse events will be recorded during the whole study period. Haematology, biochemistry, urine tests will be monitored before and after 68Ga-DOTATOC injection (at screening, Day 0, Day 7 and Day 28). Vital signs will be recorded at each study visit. Physical examination will be performed at screening, Day 0 (at least one hour after administration), Day 7 and Day 28. ECG will be monitored at screening and after the administration (Day 0).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): No secondary endpoint are planned in this study

Secondary ID(s)

AAA-Ga-TOC-EU-01

Source(s) of Monetary Support

Advanced Accelerator Applications SA

Ethics review

Status: Approved
Approval date:
Contact: