Clinical Trial Results:
Nintedanib (BIBF 1120) plus docetaxel in NSCLC patients progressing after first-line CTX: angiogenic biomarker identification, phase II trial
Summary
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EudraCT number |
2014-003891-22 |
Trial protocol |
AT |
Global end of trial date |
18 May 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Oct 2020
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First version publication date |
17 Oct 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 |
BIO_LUME_1
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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 |
Medical University Innsbruck
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Sponsor organisation address |
Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
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Public contact |
Priv.Doz. Dr. Andreas Pircher, Medical University Innsbruck
Department of Internal Medicine V
Anichstrasse 35
6020 Innsbruck, 43 (0)512/504-24003, andreas.pircher@i-med.ac.at
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Scientific contact |
Priv.Doz. Dr. Andreas Pircher, Medical University Innsbruck
Department of Internal Medicine V
Anichstrasse 35
6020 Innsbruck, 43 (0)512/504-24003, andreas.pircher@i-med.ac.at
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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 |
18 May 2018
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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 |
18 May 2018
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The aim of the study is to explore novel biomarkers and to evaluate biomarker combinations measured in different biosamples (plasma, whole blood, DNA, tumor tissue) when combined with clinical parameters.
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Oct 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 |
Austria: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
No patients were recruited for this trial. "99999" is a value for 0 participants. | ||||||
Pre-assignment
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Screening details |
N/A | ||||||
Period 1
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Period 1 title |
Treatment 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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Docetaxel/ Nintedanib | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Nintedanib
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Investigational medicinal product code |
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Other name |
Vargatef, BIBF 1120
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects would have recived 200mg Nintedanib twice a day.
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Investigational medicinal product name |
Docetaxel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects would have been treated using the following scheme: All patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g. 8 mg twice daily) for three days starting one day prior to docetaxel administration. Four cycles of docetaxel application should be given. Docetaxel will be administered as a one hour infusion on day one of each treatment cycle.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Docetaxel/ Nintedanib
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Reporting group description |
- |
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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 |
N/A
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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: No subjects were included in this trial, therefore no statistical analysis was done. |
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Notes [2] - "99999" is a value for 0 participants |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
30.10.2015- 18.05.2018
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Adverse event reporting additional description |
No patients were included in this trial, therefore no AEs and SAEs were reported.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4.03
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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: No subjects were included in this trial, therefore no AEs or SAEs were observed. |
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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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26 Sep 2016 |
Meldung Protokolländerung |
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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. | |||
No subjects were enrolled in this trial. "99999" is a value for 0 participants, as it was not possible to fill in "0" for the number of included patients. |