Clinical Trial Results:
Safety and tolerability of 68Ga-DOTATOC for injection in patients with proven gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs)
Summary
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EudraCT number |
2014-002741-21 |
Trial protocol |
GB |
Global end of trial date |
27 Jun 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2020
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First version publication date |
04 Jun 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AAA-Ga-TOC-EU-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Advanced Accelerator Applications SA
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Sponsor organisation address |
20 rue Diesel, Saint-Genis-Pouilly, France, 01630
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Public contact |
Novartis Clinical Disclosure Office, Advanced Accelerator Applications SA, +41 613241111 , novartis.email@novartis.com
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Scientific contact |
Novartis Clinical Disclosure Office, Advanced Accelerator Applications SA, +41 613241111 , novartis.email@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jun 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jun 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the study was to assess the safety and tolerability of a single administration of dose of 2 MBq/Kg ± 10% (range 100-200 MBq) of the kit for preparation of 68Ga-DOTATOC for injection (a radioactive diagnostic drug) in subjects with proven gastro-entero-pancreatic neuroendocrine tumors.
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Protection of trial subjects |
The study was conducted in compliance with the ethical principles of the “Declaration of Helsinki” and with the principles of Good Clinical Practice as outlined in the International Conference for Harmonization (ICH) tripartite guideline.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Jun 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was conducted at two centers in United Kingdom from 29-June-2015 (first subject enrolled) to 27-June-2016 (last subject last visit). | ||||||
Pre-assignment
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Screening details |
Twenty subjects were enrolled in the study. All enrolled subjects completed the study and were administered with 68Ga-DOTATOC injected intravenously for the purpose of medical imaging. | ||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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68Ga-DOTATOC | ||||||
Arm description |
Subjects received a single dose of 2 MBq/kg +/- 10%, but not less than 100 MBq and not more than 200 MBq, of 68Ga-DOTATOC intravenously (IV). | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
DOTA0-Tyr3-Octreotide
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Investigational medicinal product code |
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Other name |
68Ga-DOTATOC
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received a single dose of 2 MBq/kg +/- 10% of IV 68Ga-DOTATOC.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
68Ga-DOTATOC
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Reporting group description |
Subjects received a single dose of 2 MBq/kg +/- 10%, but not less than 100 MBq and not more than 200 MBq, of 68Ga-DOTATOC intravenously (IV). |
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End point title |
Number of Subjects with Adverse Events (AEs), Serious Adverse events (SAEs) and Death [1] | ||||||||||||
End point description |
AE was defined as any untoward medical occurrence in a clinical trial subject administered medicinal product and which does not necessarily have causal relationship with investigational product (IP). An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, contrast media or drugs administered during the imaging tests, whether or not considered related to the IP. SAE is any untoward medical occurrence or effect that at any dose: results in death, is life-threatening, requires hospitalization, or prolongation of existing inpatient's hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect. This analysis was performed in safety set (SS). SS consisted of all subjects who took at least one dose of study medication.
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End point type |
Primary
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End point timeframe |
From start of the study up to follow up (Day 28)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive statistics was planned for this endpoint. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From start of study up to follow up (Day 28)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
68Ga-DOTATOC
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Reporting group description |
Subjects received a single dose of 2 MBq/kg +/- 10%, but not less than 100 MBq and not more than 200 MBq, of 68Ga-DOTATOC intravenously (IV). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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10 Oct 2014 |
Protocol amendment due to MHRA and EC comments. Initial version 1.0 was never applicable on-site. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Novartis acquired Advanced Accelerator Applications SA. |