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, this trial enrolled 109 people across four groups. Twenty-six participants received the study drug (RO5185426, also known as vemurafenib) in an original tablet formulation at escalating doses, 30 received a modified formulation at escalating doses, 32 had BRAF-mutation-positive melanoma in an extension phase, and 21 had BRAF-mutation-positive bowel cancer (colorectal cancer) in an extension phase. The trial was primarily measuring how the drug moved through the body — specifically how much of the drug was present in the bloodstream over time, how high the concentration peaked, and how quickly it reached that peak. The reported data shows the following for the original formulation dose-escalation group. On Day 1, the amount of drug measured in the blood over eight hours (a standard way researchers track how much of a medicine the body absorbs) ranged from 2.02 to 4.47 micrograms per millilitre per hour across the four dose levels (200 mg, 400 mg, 800 mg, and 1600 mg). By Day 15, those same figures had risen considerably, ranging from 9.37 to 33.89, suggesting the drug built up in the body over time. The highest blood concentration reached on a single dose (Day 1) ranged from 0.37 to 0.85 micrograms per millilitre, and by Day 15 this had increased to between 1.34 and 5.41 micrograms per millilitre. The time it took to reach peak concentration on Day 1 ranged from about 3 to 10 hours depending on dose. No outcome data for the modified formulation group or the extension-phase groups was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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 have a solid tumor that has been confirmed by a tissue test, and either it has stopped responding to standard treatments, or no standard or curative treatment exists for your condition.
- If you are in a specific group requiring tissue samples (biopsies), you must have a particular gene change called "V600E+ BRAF mutation" confirmed before starting the study drug.
- Any previous chemotherapy, immunotherapy, or radiation therapy must have been finished at least 2 weeks before starting the study drug, and any side effects from those treatments must have cleared up.
- If you are joining the melanoma or colorectal cancer groups specifically, you must have the V600E+ BRAF mutation AND have measurable tumors, and you must be able to provide a tumor tissue sample (either stored or fresh) for testing.
- You must be relatively active and able to care for yourself, with only limited restrictions on physical activity (confirm with trial site).
- Your life expectancy is expected to be at least 3 months or more.
- Your blood counts, liver, and kidney are functioning well enough as shown by recent lab tests.
Who may not be able to join:
- You have cancer that has spread to the brain and is getting worse, has only been stable for less than 3 months, or requires steroid medication to manage it.
- You have taken another experimental or investigational drug within the past 28 days before starting this trial.
- You have another serious illness or health condition that is not well controlled.
- You have severe, ongoing nausea and vomiting, a condition affecting how your body absorbs food, or have had a significant portion of your bowel surgically removed, which could prevent the study drug from being properly absorbed.
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.
GP referral letter
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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 (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation; Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation; Peak Concentration (Cmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation; Peak Concentration (Cmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation; Time to Peak Concentration (Tmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation; Time to Peak Concentration (Tmax) of RO5185426 on Day 15 - Dose Escalation: Original Formul...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.