Clinical Trial Results:
Epirubicin as 2nd line treatment to patients with TOP2A gene amplified and oxaliplatin refractory metastatic colerectal cancer
Summary
|
|
EudraCT number |
2013-001648-79 |
Trial protocol |
DK |
Global end of trial date |
31 Dec 2017
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
31 Jan 2020
|
First version publication date |
31 Jan 2020
|
Other versions |
|
Summary report(s) |
Epirubicin BMC Cancer |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
KFE13.10
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Odense University Hospital
|
||
Sponsor organisation address |
JB Winslowsvej 4, Odense C, Denmark, 5000
|
||
Public contact |
Per Pfeiffer, Odense University Hospital, +45 65413834, per.pfeiffer@rsyd.dk
|
||
Scientific contact |
Per Pfeiffer, Odense University Hospital, +45 65413834, per.pfeiffer@rsyd.dk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Interim
|
||
Date of interim/final analysis |
31 Dec 2017
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
31 Dec 2017
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Progression-free survival
|
||
Protection of trial subjects |
Progression-free survival
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Sep 2013
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 6
|
||
Worldwide total number of subjects |
6
|
||
EEA total number of subjects |
6
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
5
|
||
From 65 to 84 years |
1
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
To be eligible for inclusion, patients must provide written informed consent, age of 18 years, WHO performance status 0–2, a life expectancy of at least 3 months, histologically verified, non-resectable, oxaliplatin resistant mCRC, and the TOP2A/CEN-17 ratio and this ratio has to be ≥ 1.5. Periode: 02.09.13-31-12-17 | ||||||
Pre-assignment
|
|||||||
Screening details |
To be eligible for inclusion, patients must provide written informed consent, age of 18 years, WHO performance status 0–2, a life expectancy of at least 3 months, histologically verified, non-resectable, oxaliplatin resistant mCRC, and the TOP2A/CEN-17 ratio and this ratio has to be ≥ 1.5. | ||||||
Period 1
|
|||||||
Period 1 title |
overall period
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
|
||||||
Blinding used |
Not blinded | ||||||
Blinding implementation details |
Non
|
||||||
Arms
|
|||||||
Arm title
|
No randomization | ||||||
Arm description |
- | ||||||
Arm type |
Treatment | ||||||
Investigational medicinal product name |
Epirubicin
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
|
||||||
Routes of administration |
Intravenous use
|
||||||
Dosage and administration details |
900 mg /m2 every 3th week
|
||||||
|
|
|
|||
End points reporting groups
|
|||
Reporting group title |
No randomization
|
||
Reporting group description |
- |
|
|||||||||
End point title |
Progression-free survival [1] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
From inclusion to progressive disease
|
||||||||
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: This is a single arm study - statistic analysis is described in the article. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
02.09.2013-31.12.2017
|
||
Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
|
|||
Dictionary name |
CTCAE | ||
Dictionary version |
4.0
|
||
Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: We do not experience any non-SAE in the few patients included. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Early termination due to slow recruitment. |