Can a liver cancer drug stop eye cancer spread?
NCT ID NCT02517736
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the drug sorafenib (Nexavar) in 32 adults with uveal melanoma that had spread to other parts of the body. The goal was to see if the drug could stop tumors from growing for at least 24 weeks. Sorafenib is already used for other cancers, and researchers wanted to know if it could help people with this rare eye cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sorafenib (Nexavar)
- What this could lead to
- If it works, this could provide a treatment option to slow tumor growth in patients with metastatic uveal melanoma.
- What could go wrong
- This is a small, early-phase trial with only 32 participants, so results may not apply broadly. Sorafenib can cause side effects like fatigue, diarrhea, and skin reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2012
- Finished
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Jan 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female over 18 years old suffering from uveal melanoma with metastasis * At least one measurable metastases by more than 10 mm acoording to Response Evaluation Criteria in Solid Tumors (RECIST) * At least 28 days from the previous treatment (systemic or major surgery) * Performance Index (WHO ≤ 2 or ≥ 70% Karnofsky) * Weight loss compared to pre morbid weight \<20% in the last 12 months * White blood cells at least 3000 / mm 3, polynuclear neutrophils less than 1500 / mm3, platelets at least 100,000 / mm3, hemoglobin at least 9.0 g / dl * Total Bilirubin ≤1.5 x upper limit of normal (ULN) (or less than or equal to 2.5 in liver metastasis), ASAT and ALAT ≤ 2.5 x ULN (or ≤ 5 in liver metastasis) Serum Creatinine (calculated using the cockcroft-Gault method) ≤ 1.5 x ULN, Amylase and lipase \<1.5 x ULN * prothrombin rate and international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Possibility of using low molecular weight heparin in place of anti vitamin K treatment * higher life expectancy than or equal to 3 months * Negative pregnancy test for women of childbearing age and using a method of contraception during treatment * No one benefiting from a Social Security scheme * Informed consent and signed by the patient or his legal representative Exclusion Criteria: * • Patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication * Major surgery (excluding the possible diagnostic biopsy) or radiation therapy in the 4 weeks preceding the inclusion * single liver metastasis treatable by surgery * active peptic ulcer, uncontrolled * Other progressive malignancy or during treatment (except basal cell carcinoma) * Cardiac arrhythmias requiring anti-arrhythmic (excluding beta-blockers or digoxin for chronic atrial fibrillation), active or ischemic coronary disease (myocardial infarction within the last 6 months), or heart failure\> New York Heart Association (NYHA) class II * Bacterial or fungal infection active (grade\> 2 Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03) * known HIV infection or chronic hepatitis B or C * cerebral or meningeal tumor metastasis (symptomatic or asymptomatic) * epileptic disease requiring anti-epileptic taken * Previous history of organ transplantation or peripheral stem cells * Patient kidney dialysis * Concomitant treatment with cytochrome P450 3A4 (CYP3A4) inducers such as rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone * Prior therapy with bevacizumab or other targeted therapy * Known or suspected allergy to sorafenib * Any unstable chronic illness can jeopardize patient safety or its compliance * Women pregnant or lactating * coagulopathy * Uncontrolled hypertension * Inability to swallow * Failure to submit to medical monitoring of the trial due to geographical, social or psychic * Persons deprived of liberty or under supervision * Patient refusing ambulatory care * Patient simultaneously participating in another clinical trial
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service d'ophtalmologie, CHU de Caen
Caen, 14000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can flooding the liver with chemotherapy stop ocular melanoma?
- Liver-Targeted immune cell attack tested against melanoma spread
- Can a pill combo keep uveal melanoma from coming back?
- Can tracking a rare eye cancer pave the way for new treatments?
- Can a new drug tame advanced solid tumors?
- Can a single eye injection shrink melanoma and save sight?