A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by AB Science.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT00998751
First received: October 19, 2009
Last updated: September 19, 2012
Last verified: September 2012

October 19, 2009
September 19, 2012
June 2005
January 2014   (final data collection date for primary outcome measure)
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998751 on ClinicalTrials.gov Archive Site
Progression Free Survival [ Time Frame: until disease progression ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastro-intestinal Stromal Tumours
Drug: oral masitinib
7.5 mg/kg/day
Other Name: AB1010
Experimental: masitinib (AB1010)
oral masitinib 7.5 mg/kg/day
Intervention: Drug: oral masitinib
Le Cesne A, Blay JY, Bui BN, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female patients, age >18
  • Life expectancy > 6 months
  • Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST.
  • Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy
  • C-Kit (CD117) positive tumors detected immuno-histochemically
  • Measurable tumor lesions with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan

Exclusion Criteria:

  • Documented allergy to the similar drug of AB1010
  • Inadequate organ function
  • Patients with a history of any other malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00998751
AB04016
No
AB Science
AB Science
Not Provided
Not Provided
AB Science
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP