Phase 1 Melanoma Trial, Terminated NCT01519323 Sponsor: Hoffmann-La Roche Condition: Melanoma
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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 involved six people in total, split into two small groups of three — one group received a lower dose of the drug vemurafenib and the other received a higher dose. The trial was exploring what the maximum tolerated dose of vemurafenib would be when combined with another treatment, and was also looking at how the drug moved through the body, how participants' tumours responded, and how long it took before disease progressed. The reported data shows that the primary goal — establishing a maximum tolerated dose — did not produce a reported numerical result in the submitted data, so that figure is not available here. For the measure of how much of the drug was present in the bloodstream over time (a way of tracking how the body absorbs and processes the medicine), the lower-dose group had reported values of 16,300 and 486,000 units, while the higher-dose group had reported values of 57,000 and 963,000 units across two different time points. All six participants were reported to have experienced at least one adverse event (an untoward medical occurrence during the study). When it came to tumour response, the reported data shows that 0% of participants had their tumour shrink or disappear entirely. However, approximately 67% of participants (roughly 4 out of 6) were reported to have achieved either a response or stable disease lasting at least six weeks. The reported median time before disease progressed was 134.5 days. It is worth noting that with only six participants, this was a very early-stage, small trial primarily designed to explore dosing rather than draw broad conclusions. 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, Terminated

NCT01519323
Terminated Phase 1 🇦🇺 Australian site

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 are between 12 and 17 years old (inclusive)
  • You have been diagnosed with advanced melanoma (skin cancer) that cannot be removed by surgery, at a serious stage (Stage IIIC or Stage IV)
  • Your cancer has tested positive for a specific gene change called a BRAF V600 mutation, using a specific approved test
  • Your cancer can be measured on scans according to standard guidelines
  • You are well enough to carry out some daily activities, as measured by a standard health score (confirm with trial site for exact score required)
  • Your bone marrow, liver, and kidneys are working well enough as shown by blood tests
  • Any side effects from previous cancer treatments have fully cleared up before starting this trial

Who may not be able to join:

  • You have cancer that has spread to the brain or spinal cord and is not yet being treated, or is still active
  • You have a history of, or known pressure on the spinal cord, or cancer spreading to the fluid around the brain or spine
  • You are currently receiving or planning to receive other cancer treatments alongside this trial
  • You have had another type of cancer in the past 5 years (with some exceptions, such as certain minor skin cancers or early-stage cervical changes — confirm with trial site)
  • You have previously been treated with a specific type of drug that targets the BRAF or MEK pathways (note: a drug called sorafenib is an exception and may be allowed)
  • You have previously taken the study drug (RO5185426) or taken part in another trial involving this drug
  • You are currently pregnant or breastfeeding
  • You have HIV, AIDS-related illness, or an active hepatitis B or hepatitis C infection

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

, Westmead, New South Wales
, Brisbane, Queensland

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
1 January 2013
Est. completion
1 December 2015

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇵🇱 Poland 🇸🇰 Slovakia 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Maximum Tolerated Dose (MTD)/Recommended Dose

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov