MelanomaPhase 2O-Mel-InibNCT00421317
Imatinib in Adult Patients With Metastatic Ocular Melanoma
A Phase 2 study testing Imatinib in people with Melanoma, run by Centre Oscar Lambret at 12 sites in France.
Trial summary
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Imatinib
- How many people
- 13 participants
- Where
- 12 sitesFrance
- Study dates
- Dec 2005to 15 Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre Francois Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges-Francois Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Hospitalier Regional Universitaire
Lille, 59035
Centre Leon Berard
Lyon, 69373
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298
Institut Curie
Paris, 75248
Centre Paul Strauss
Strasbourg, 67065
Hopital Universitaire de Hautepierre
Strasbourg, 67098
Institut Claudius Regaud
Toulouse, 31052
Centre Gustave Roussy
Villejuif, 94805
About this study
Official title: 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.
Read the detailed description
Further study details as provided by Centre Oscar Lambret
- Conditions
- Melanoma
- Being tested
- Imatinib
- Keywords
- Ocular, Metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
800 mg/day until disease progression or toxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free rate at 3 months
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startDec 2005
- Primary completion15 Nov 2009
- Study completion15 Nov 2009
Why it stopped: Study stopped at the end of the first step
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- PENEL Nicolas, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421317
- Sponsor's protocol ID
- O-Mel-Inib-0508
- Acronym
- O-Mel-Inib
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2007
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
- ClinicalTrials.gov ID
- NCT00421317
- Acronym / sponsor ID
- O-Mel-Inib / O-Mel-Inib-0508
- Conditions
- Melanoma
- Keywords
- Ocular, Metastatic melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped at the end of the first step
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Novartis, National Cancer Institute, France
- Study start
- Dec 2005 (actual)
- Primary completion
- 15 Nov 2009 (actual)
- Study completion
- 15 Nov 2009 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib800 mg/day until disease progression or toxicity | Drug | – |
Primary outcome
Progression-free rate at 3 months
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Study stopped at the end of the first step). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PENEL Nicolas, MD principal investigator
Centre Oscar Lambret
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib in people with Melanoma, run by Centre Oscar Lambret at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped at the end of the first step). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free rate at 3 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.