|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 September 2012 |
|
Main ID: |
EUCTR2011-001790-41-ES |
|
Date of registration:
|
07/08/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
N/A
|
|
Scientific title:
|
N/A -
|
|
Date of first enrolment:
|
12/09/2012 |
|
Target sample size:
|
208 |
|
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001790-41 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Spain
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Catherine Léger
|
|
Address:
|
3, avenue Georges V
75008
Paris
France |
|
Telephone:
|
+33147 20 66 76NA |
|
Email:
|
catherine.leger@ab-science.com |
|
Affiliation:
|
AB Science |
|
|
Name:
|
Catherine Léger
|
|
Address:
|
3, avenue Georges V
75008
Paris
France |
|
Telephone:
|
+33147 20 66 76NA |
|
Email:
|
catherine.leger@ab-science.com |
|
Affiliation:
|
AB Science |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 208
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
Therapeutic area: Diseases [C] - Cancer [C04]
|
MedDRA version: 14.1
Level: LLT
Classification code 10062427
Term: Gastrointestinal stromal tumor
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Intervention(s)
|
Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790299-79-5
Current Sponsor code: AB1010
Other descriptive name: MASITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: SUTENT
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
CAS Number: 557795-19-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790299-79-5
Current Sponsor code: AB1010
Other descriptive name: MASITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
|
|
Primary Outcome(s)
|
|
Main Objective:
|
|
Primary end point(s):
|
|
Secondary Objective:
|
|
Source(s) of Monetary Support
|
|
AB Science
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|