Clinical Trial Results:
A Safety and feasibility study of standard dosing day 1 carboplatin AUC 5 every 3rd weeks with daily Navelbine® 20/30mg (oral) during 4 cycles (12 weeks) for the treatment of advanced NSCLC; A feasibility study
Summary
|
|
EudraCT number |
2017-000659-23 |
Trial protocol |
DK |
Global end of trial date |
08 Oct 2020
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Mar 2022
|
First version publication date |
08 Mar 2022
|
Other versions |
|
Summary report(s) |
Metronomic oral vinorelbine doublet chemotherapy with carboplatin in treatment of advanced lung cancer: a feasibility and safety study |
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 |
220365-2017
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
AUH, kræftafdeling
|
||
Sponsor organisation address |
Valdemars Have 28, 3. tv., Aarhus C, Denmark, 8000
|
||
Public contact |
Clinical Research Unit (KFE), Aarhus University Hospital (AUH) , mariakandi@gmail.com
|
||
Scientific contact |
Clinical Research Unit (KFE), Aarhus University Hospital (AUH) , +45 29906907, mariakandi@gmail.com
|
||
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 |
Final
|
||
Date of interim/final analysis |
08 Oct 2020
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
28 Feb 2019
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
08 Oct 2020
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Primary objectives:
Evaluating the side effects (toxicity and feasibility, adverse events grade 2-5 (CTC)) during the first 84 days (12 weeks) of treatment.
|
||
Protection of trial subjects |
Trial subjects reported any toxicity, that occurred between cycles or in between visits. Moreover, during the entire treatment period trial subjects kept a diary. The subjects were asked to register any adverse event in their diary. Five visits were scheduled during the treatment period.
|
||
Background therapy |
Carboplatinum was given as backbone treatment to all trial subjects accordingly to national guidelines. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2018
|
||
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: 20
|
||
Worldwide total number of subjects |
20
|
||
EEA total number of subjects |
20
|
||
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) |
8
|
||
From 65 to 84 years |
12
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
01/may/2018 -28/feb/2019. Dept. of Oncology, Aarhus University Hospital, Denmark. | ||||||
Pre-assignment
|
|||||||
Screening details |
Subjects with incurable NSCLC, candidates for 1st-line chemotherapy (PD-L1<50%), were included. | ||||||
Period 1
|
|||||||
Period 1 title |
From May 2018 to February 2019 (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Arms
|
|||||||
Arm title
|
active comparator | ||||||
Arm description |
the study is open label non randomized study | ||||||
Arm type |
open label non randomized arm | ||||||
Investigational medicinal product name |
vinorelbine
|
||||||
Investigational medicinal product code |
L01CA04
|
||||||
Other name |
|||||||
Pharmaceutical forms |
Capsule, soft
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
20/30 mg daily in maximum 12 weeks in combination with carboplatinum (given every 3 weeks max 4 series)
|
||||||
|
|
|||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
From May 2018 to February 2019
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
active comparator
|
||
Reporting group description |
the study is open label non randomized study |
|
|||||||||||
End point title |
toxicity [1] | ||||||||||
End point description |
|||||||||||
End point type |
Primary
|
||||||||||
End point timeframe |
May 2018 - June 2019
|
||||||||||
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 pilot and safety study with only 20 patients whose toxicity and data were descriptive. |
|||||||||||
|
|||||||||||
Notes [2] - 18 patient was included in toxicity data |
|||||||||||
No statistical analyses for this end point |
|
|||
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
All adverse events on subjects were registered from baseline and until end of treatment period for last trial subject.
|
||
Adverse event reporting additional description |
Trial subjects were instructed to report any toxicity, that occurred between cycles or in between visits, using an electronic adverse event report system (AmbuFlex(R)). Moreover, during the entire treatment period subjects kept a diary.
|
||
Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
|
|||
Dictionary name |
CTCAE | ||
Dictionary version |
4.03
|
||
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: see reported table over adverse events section in attached PDF file |
|
|||
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. | |||
None reported |