Clinical Trial Results:
Phase II study with temozolomide and capecitabine for patients with refractory colorectal cancer.
Summary
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EudraCT number |
2012-002327-15 |
Trial protocol |
DK |
Global end of trial date |
21 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Mar 2021
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First version publication date |
11 Mar 2021
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Other versions |
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Summary report(s) |
TEM poster |
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 |
KFE12.05
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
J.B. Winsløws Vej 4, Entrance 140, basement, Odense C , Denmark, 5000
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Public contact |
Ida Coordt Elle, Odense University Hospital, +45 29335922, Ida.Coordt.Elle@rsyd.dk
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Scientific contact |
Per Pfeiffer, Odense University Hospital, +45 26283844, Per.Pfeiffer@rsyd.dk
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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 |
01 Sep 2015
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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 |
21 Sep 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 |
To investigate a new treatment regimen for pre-treated patients with metastatic colorectal cancer.
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Protection of trial subjects |
Administration of pre-medication to minimize nausea.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 42
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Worldwide total number of subjects |
42
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EEA total number of subjects |
42
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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) |
14
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From 65 to 84 years |
28
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85 years and over |
0
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Recruitment
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Recruitment details |
29.05-2013-08.10.2015 | ||||||
Pre-assignment
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Screening details |
Pre-treated patients with KRAS-mutated metastatic colorectal cancer. | ||||||
Period 1
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Period 1 title |
Trial period (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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Experimental | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Temozolomide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
150 mg/m2 on days 10-14 of four-week-cycles.
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Investigational medicinal product name |
Capecitabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2000 mg/m2 on days 1-14 during four-week-cycles.
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Baseline characteristics reporting groups
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Reporting group title |
Trial period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Analysis of all patients.
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
- | ||
Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Analysis of all patients.
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End point title |
Progression-free survival [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months
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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: Please see attached summary for further details. |
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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 |
Last treatment + 30 days.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
Patients
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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. | |||
None reported |