Imatinib in Adult Patients With Metastatic Ocular Melanoma | NCT00421317

Studies
Imatinib in Adult Patients With Metastatic Ocular Melanoma

NCT00421317

Sponsor

Centre Oscar Lambret

Status

Terminated

Last Update Posted

Mar 13, 2026Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Melanoma

Interventions

Imatinib

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study stopped at the end of the first step

Expanded Access Info

Start Date

Dec 2005Actual

Primary Completion Date

Nov 15, 2009Actual

Completion Date

Nov 15, 2009Actual

First Submitted Date

Jan 9, 2007

First Submission Date that Met QC Criteria

Jan 9, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 13, 2026Actual

Name	Class
Novartis	INDUSTRY
National Cancer Institute, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
Imatinib	Drug	800 mg/day until disease progression or toxicity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free rate at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free rate at 6 and 12 months
Response rate according to RECIST criteria
Toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PENEL Nicolas, MD	Centre Oscar Lambret	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Francois Baclesse		Caen		14076	France
Centre Jean Perrin

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided