Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, 52 people took part in this trial, all grouped together under a single treatment arm receiving the drug vemurafenib. Participants were divided into four smaller groups (called cohorts), each receiving a different dose: 240 mg, 480 mg, 720 mg, or 960 mg. The trial was primarily measuring how the drug moves through the body — specifically, how much of it gets into the bloodstream and how quickly — at these different dose levels. It is worth noting that none of the 52 participants were recorded as having "completed" the study in the formal sense used in the data, though this may reflect how completion was defined for this particular trial rather than meaning participants dropped out. The reported data shows that on the first day of dosing, the peak amount of vemurafenib measured in the blood ranged from 1.9 micrograms per millilitre (mcg/mL) in the lowest-dose group up to 4.8 mcg/mL in the highest-dose group. The time it took to reach that peak level was reported as 4 hours for the two lower-dose groups and 5 hours for the two higher-dose groups. A measure of the total drug exposure over 24 hours on Day 1 — essentially the area under a graph plotting drug levels over time — was reported as 40.9 units for the 240 mg group, rising to 130.6 units for the 960 mg group. By Day 9 of dosing, the reported data shows that drug levels in the blood were considerably higher than on Day 1 across all groups, with peak blood levels ranging from 15.4 mcg/mL (240 mg group) to 53.2 mcg/mL (960 mg group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 24983357) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Melanoma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be an adult aged 18 or older
- You must have been diagnosed with advanced melanoma (a type of skin cancer) that has spread, classified as stage IIIc or stage IV
- You must have already tried at least one standard treatment for your melanoma that did not work
- Your tumor must test positive for a specific gene change called the BRAF V600E mutation, confirmed by a specific approved test
- You must be in reasonably good general health and able to carry out normal daily activities with little or no limitation (confirm with trial site)
- Your blood, kidneys, and liver must be functioning well enough to meet the trial's requirements
Who may not be able to join:
- You cannot join if you have active cancer lesions in your brain or spinal area, confirmed by a scan within the 28 days before enrolling
- You cannot join if you have a history of your spinal cord being compressed by cancer, or cancer spreading to the membranes around your brain or spinal cord
- You cannot join if you are currently receiving or planning to receive any other cancer treatments outside of this trial
- You cannot join if you have previously been treated with certain targeted drugs known as BRAF inhibitors (though one called sorafenib is allowed) or MEK inhibitors
- You cannot join if you have had serious heart or blood vessel problems within the 6 months before the study
- You cannot join if you have had another type of cancer in the past 5 years, with exceptions for certain common skin cancers and a specific early-stage cervical condition (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 1; Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 1; Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 1; Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 1; Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 9; Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 9; Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.