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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2007

Last Updated Date

August 10, 2012

Start Date ^ICMJE

December 2005

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free rate at 3 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00421317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Imatinib in Adult Patients With Metastatic Ocular Melanoma

Official Title ^ICMJE

A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

Brief Summary

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

Detailed Description

Further study details as provided by Centre Oscar Lambret

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

Drug: Imatinib

800 mg/day until disease progression or toxicity

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00421317

Other Study ID Numbers ^ICMJE

2005-08

Has Data Monitoring Committee

Responsible Party

Centre Oscar Lambret

Study Sponsor ^ICMJE

Centre Oscar Lambret

Collaborators ^ICMJE

Novartis
National Cancer Institute, France

Investigators ^ICMJE

Principal Investigator:

PENEL Nicolas, MD

Centre Oscar Lambret

Information Provided By

Centre Oscar Lambret

Verification Date

August 2012

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

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