Clinical Trial Results:
An open label multicentric phase II study of Panitumumab (Vectibix®) in cutaneous squamous cell carcinoma (SCC)
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Summary
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EudraCT number |
2009-015237-76 |
Trial protocol |
BE |
Global end of trial date |
17 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Mar 2021
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First version publication date |
17 Mar 2021
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Other versions |
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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 |
LUC 09-002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01129154 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cliniques universitairtes Saint-Luc
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Sponsor organisation address |
Avenue Hippocrate, 10, Brussels, Belgium, 1200
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Public contact |
Jean-François Baurain, Cliniques universitaires Saint-Luc, +32 2 7645471, jean-francois.baurain@uclouvain.be
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Scientific contact |
Jean-François Baurain , Cliniques universitaires Saint-Luc, +32 2 7645471, jean-francois.baurain@uclouvain.be
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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 Jun 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jul 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Jan 2017
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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 |
Overall Response Rate (ORR)
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) régulations/guidelines, and country-specific national and local laws.
Description AE management in the protocol.
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Background therapy |
PANITUMUMAB (Vectibix®) | ||
Evidence for comparator |
No active RI in this discase at this stage. | ||
Actual start date of recruitment |
10 Sep 2010
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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 |
Belgium: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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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) |
3
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From 65 to 84 years |
7
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85 years and over |
8
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Recruitment
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Recruitment details |
Dermatology consultation from September 2010 till May2016. | ||||||||||
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Pre-assignment
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Screening details |
NA | ||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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PANITUMUMAB – Vectibix ARM | ||||||||||
Arm description |
Experimental treatment | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
PANITUMUMAB
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Investigational medicinal product code |
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Other name |
Vectibix
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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 |
6 mg/kg p 2 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
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End points reporting groups
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Reporting group title |
PANITUMUMAB – Vectibix ARM
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Reporting group description |
Experimental treatment | ||
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End point title |
Overall Response Rate (ORR) [1] | ||||||||
End point description |
To measure the efficacy of Panitumumab for SCC in terms of Overall Response Rate (ORR). Overall Response Rate (ORR) is defined as the sum of complete and partial tumour responses seen, divided by the total number of evaluable patients. Imaging evaluation will be done via photography and CT-scan, MRI or PET-scan every 6 weeks on 2 occasions, then every 12 weeks. Response evaluation will be assessed according Modified RECIST version 1.1. Patient will be declared progressive at that time if their clinical situation requires an immediate alternative treatment. Response evaluation will be assessed at week 12. Best observed response will also be recorded.
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End point type |
Primary
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End point timeframe |
Via imaging every 12 weeks
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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: Only descriptive statistical analysis has been performed. ORR and duration of response measured according to modified RECIST version 1.1. Responders and non-responders subjects compared for their demographic parameters, by Fisher exact and Student T tests, according to the type of variables. The Kaplan-Meier technique used to obtain the TTF and the TTP. Subjects without evidence of progression at the end of follow up considered as censored. Proportion of all adverse events are reported. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression free survival (PFS) | ||||||||
End point description |
PFS is defined as the time from date of first dose of study medication to first occurrence of any following event: documentation of objective tumor progression, toxicities requiring prematurely stop of treatment or death.
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End point type |
Secondary
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End point timeframe |
Via imaging, every 12 weeks.
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| No statistical analyses for this end point | |||||||||
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End point title |
overall survival (OS) | ||||||||
End point description |
Duration of overall response measured according RECIST guidelines version 1.1. Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
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End point type |
Secondary
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End point timeframe |
Via imaging, every 12 weeks.
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Adverse events information
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Timeframe for reporting adverse events |
All Serious AE occurring at any time after the patient has signed the informed consent, the screening visit, and within 30 days of the last day on which the investigational agent was administered must be reported within 24 hours of awareness of the event.
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Adverse event reporting additional description |
Adverse Events attributes assigned by the investigator: AE diagnosis or syndrome(s); event description; dates of onset and resolution; severity; assessment of relatedness to study treatment; and action taken.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
3.0
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Reporting groups
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Reporting group title |
PANITUMUMAB - Vectibix ARM
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Reporting group description |
6 SAE occurred in study, all due to a patient hospitalization. The 6 were not related to the study drug, and 3 resolved without sequelae. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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04 Nov 2009 |
1.1 Protocol classification |
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29 Dec 2009 |
1.2 Protocol classification |
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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. | |||
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