Clinical Trial Results:
Open-Label, Non-Randomized Study of U3-1287 in Combination with Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer
Summary
|
|
EudraCT number |
2013-000104-42 |
Trial protocol |
DE |
Global end of trial date |
09 Apr 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
09 Apr 2016
|
First version publication date |
09 Apr 2016
|
Other versions |
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 |
U31287-A-U201E
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Daiichi Sankyo Development Limited
|
||
Sponsor organisation address |
Chiltern Place, Chalfont Park, Gerrards Cross, United Kingdom, SL9 0BG
|
||
Public contact |
Clinical Trial Information, Daiichi Sankyo Development Limited, 44 1753 482800, info@dsd-eu.com
|
||
Scientific contact |
Clinical Trial Information, Daiichi Sankyo Development Limited, 44 1753 482800, info@dsd-eu.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 |
19 Jan 2015
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
09 Apr 2014
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
09 Apr 2014
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To allow continuation of study treatment for subjects who have demonstrated clinical benefit (stable disease or better) at the time of study closure for U31287-A-U201.
|
||
Protection of trial subjects |
The study was conducted in compliance with ethical principles that have their origin in the Declarations of Helsinki the International Conference on Harmonisation (ICH) consolidated Guideline E6 for Good Clinical Practice (GCP) (CPMP/ICH/135/95), and applicable regulatory requirement(s):
• USA FDA GCP guidelines;
• USA Code of Federal Regulations Title 21, parts 11, 50, 54, 56, and 312;
• EU Directive 2001/20/EC Implementation of good clinical practice in the conduct of clinical studies on medicinal products for human use;
• EU Directive 2005/28/EC: Laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products;
• Other applicable regulations.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Nov 2013
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Romania: 2
|
||
Country: Number of subjects enrolled |
Germany: 2
|
||
Worldwide total number of subjects |
4
|
||
EEA total number of subjects |
4
|
||
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) |
1
|
||
From 65 to 84 years |
3
|
||
85 years and over |
0
|
|
||||||||||||||||
Recruitment
|
||||||||||||||||
Recruitment details |
Subjects who demonstrated clinical benefit (SD or better) at the time of study closure for U31287-A-U201, continued study treatment as last received in U31287-A-U201. | |||||||||||||||
Pre-assignment
|
||||||||||||||||
Screening details |
The open-label treatment assigned to each subject continuing under this protocol corresponded to the subject’s randomly assigned treatment received under protocol U31287-A-U201 with the exception of placebo. | |||||||||||||||
Period 1
|
||||||||||||||||
Period 1 title |
Treatment period (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
|
|||||||||||||||
Blinding used |
Not blinded | |||||||||||||||
Blinding implementation details |
N/A
|
|||||||||||||||
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
Arm title
|
Erlotinib | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Erlotinib
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Film-coated tablet
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
Commercial supplies of erlotinib were used. Erlotinib 150 mg or 100 mg tablet was self-administered PO QD. On the day of patritumab administration, erlotinib was taken after the infusion of patritumab was completed. Erlotinib was to be taken 1 h before or at least 2 h after meals.
|
|||||||||||||||
Arm title
|
Erlotinib + Patritumab | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Erlotinib
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Film-coated tablet
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
Commercial supplies of erlotinib were used. Erlotinib 150 mg or 100 mg tablet was self-administered PO QD. On the day of patritumab administration, erlotinib was taken after the infusion of patritumab was completed. Erlotinib was to be taken 1 h before or at least 2 h after meals.
|
|||||||||||||||
Investigational medicinal product name |
Patritumab
|
|||||||||||||||
Investigational medicinal product code |
U3-1287
|
|||||||||||||||
Other name |
AMG 888
|
|||||||||||||||
Pharmaceutical forms |
Solution for infusion
|
|||||||||||||||
Routes of administration |
Intravenous use
|
|||||||||||||||
Dosage and administration details |
Patritumab infusions were administered every 3 weeks. Patritumab was administered as a continuous intravenous infusion over 60 minutes (± 10 minutes). Infusion times could be extended to a maximum of 120 minutes for subjects unable to tolerate the 60 minute infusion.
|
|||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment period
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Erlotinib
|
||
Reporting group description |
- | ||
Reporting group title |
Erlotinib + Patritumab
|
||
Reporting group description |
- |
|
||||||||||
End point title |
Safety - Adverse Events [1] | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Until up to 60 days after end of treatment
|
|||||||||
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: The primary objective of U31287-A-U201E was to allow continuation of study treatment for subjects who demonstrated clinical benefit (stable disease [SD] or better) at the time of study closure for U31287-A-U201. Safety data were collected but analysis was descriptive only due to small sample size. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
AEs were reported from time of Informed Consent to the EOT visit assessment and up to 53 days after the last dose of U3-1287, or, if U3-1287 was discontinued earlier or if subject received erlotinib alone, up to 30 days after the last dose of erlotinib
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Erlotinib
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Erlotinib + Patritumab
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
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. | |||
Although 1 subject was assigned the patritumab erlotinib combo on U201, they were on erlotinib and placebo at end of U201 and therefore only received erlotinib on U201E. |