Clinical Trial Results:
Traitement des carcinomes à cellules de Merkel inopérables et/ou métastatiques par analogue de la somatostatine – Etude nationale multicentrique mono-bras de phase II.
Summary
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EudraCT number |
2014-001273-13 |
Trial protocol |
FR |
Global end of trial date |
15 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Jul 2022
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First version publication date |
17 Jul 2022
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Other versions |
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Summary report(s) |
document justifying the missing/partial results _ PHRC MERKEL |
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 |
38RC14.040
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02351128 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Grenoble Alpes University Hospital
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Sponsor organisation address |
CS 10217, Grenoble , France, 38043
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Public contact |
CIC Cancérologie, University Hospital of Grenoble , 33 476769481, ChMendoza@chu-chu-grenoble.fr
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Scientific contact |
Cancérologie, University Hospital of Grenoble , 33 4 76 76 70 81, SMouret@chu-chu-grenoble.fr
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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 |
29 Mar 2021
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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 |
15 May 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 |
To assess the efficacy of lanreotide at 3 months in patients with inoperable and/or metastatic Merkel cell carcinoma (MCC).
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Protection of trial subjects |
Treatment of localized forms of MCC is currently based on surgery and radiotherapy, but when patients are in the metastatic stage no survival benefit has been demonstrated using chemotherapy, unlike other neuroendocrine tumors. The prognosis for patients with stage IV disease is severe with a 1-year survival of about 44%.
Chemotherapy is therefore currently considered a palliative treatment in case of disseminated disease. In this context we can offer this treatment to these patients. The clinical benefits of this treatment have been observed in some patients without side effects. This treatment already has MA in other indications and is well tolerated.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Apr 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
24 Months | ||
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 |
France: 35
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Worldwide total number of subjects |
35
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EEA total number of subjects |
35
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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) |
2
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From 65 to 84 years |
23
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85 years and over |
10
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Inoperable or histologically confirmed merkel cell carcinoma stage III B or IV (according to AJCC 2010 classification) First line of treatment or more At least one measurable target of more than 20 mm with a conventional scanner or more than 10 mm with a spiral scanner or evaluable clinical targets | ||||||
Period 1
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Period 1 title |
lanreotide (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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intervention | ||||||
Arm description |
lanretoride | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
lanréotide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
120 mg each 28 days
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Baseline characteristics reporting groups
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Reporting group title |
lanreotide
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
intervention
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Reporting group description |
lanretoride | ||
Subject analysis set title |
One Arm
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
One Arm analysis
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End point title |
efficacy of lanreotide | ||||||||||||
End point description |
Treatment will be considered effective if 40% of patients have a positive response. The positive response is defined by all patients with either a complete response, a partial response, or a stable response according to RECIST 1.1 criteria.
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End point type |
Primary
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End point timeframe |
evaluation at 3 months of treatment
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Statistical analysis title |
Primary endpoint | ||||||||||||
Comparison groups |
intervention v One Arm
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Number of subjects included in analysis |
70
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Shapiro-Wilks | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
During all the study periods
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Assessment type |
Systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
intervention
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Reporting group description |
lanretoride | ||||||||||||||||||||||
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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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05 Jun 2015 |
Updating of the centres and associated investigators. The investigators' table is removed from the protocol and appended separately.
Somatuline SPC update, minor version update.
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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. | |||
None reported |