Imatinib in Adult Patients With Metastatic Ocular Melanoma (O-Mel-Inib)

This study has been terminated.
(Study stopped at the end of the first step)
Sponsor:
Collaborators:
Novartis
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00421317
First received: January 9, 2007
Last updated: August 10, 2012
Last verified: August 2012

January 9, 2007
August 10, 2012
December 2005
March 2007   (final data collection date for primary outcome measure)
Progression-free rate at 3 months
Same as current
Complete list of historical versions of study NCT00421317 on ClinicalTrials.gov Archive Site
  • Progression-free rate at 6 and 12 months
  • Response rate according to RECIST criteria
  • Toxicity
  • Global survival,Progression-free survival
  • Predictive genomic factors of response
Same as current
Not Provided
Not Provided
 
Imatinib in Adult Patients With Metastatic Ocular Melanoma
A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

Further study details as provided by Centre Oscar Lambret

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Drug: Imatinib
800 mg/day until disease progression or toxicity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic ocular melanoma
  • Age > or = 18 years old
  • Measurable metastases > or = 10 mm according to RECIST criteria
  • PS-WHO < or = 1 or IK > 70 percent
  • Normal hepatic function
  • PNN > 1500/mm3, platelets > or = 100 000/mm3
  • Contraception
  • Informed consent signed

Exclusion Criteria:

  • Patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association)
  • Other evolutive neoplasic disease
  • Severe hepatic insufficiency
  • Severe renal insufficiency
  • Somatic or psychiatric co-morbidity incompatible with the protocol
  • Leptomeningeal or cerebral metastatic dissemination
  • Pregnant or lactating woman
  • Other antitumoral treatment
  • Patient participating to another clinical trial with an experimental drug
  • Known hypersensitivity to Imatinib or one of its excipients
  • Resecable single metastasis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00421317
2005-08
No
Centre Oscar Lambret
Centre Oscar Lambret
  • Novartis
  • National Cancer Institute, France
Principal Investigator: PENEL Nicolas, MD Centre Oscar Lambret
Centre Oscar Lambret
August 2012

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