NO25390 Phase I Paed Melanoma

• Research type

  Research Study

• Full title

  An open-label, multicenter, single-arm, Phase I dose-escalation with efficacy tail extension study of RO5185426 in pediatric patients with surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations

• IRAS ID

  86186

• Contact name

  Julia Chisholm

• Sponsor organisation

  F. Hoffman-La Roche Ltd.

• Eudract number

  2011-000874-67

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase 1 study of the drug RO5185426 in children and teenagers aged 12-17 with stage IIIC or IV melanoma that has spread to other parts of the body (is metastatic) or cannot be removed by surgery (is unresectable). Following the promising results of this study drug with BRAF mutated melanoma in adults, this drug is being explored in a paediatric population. The purpose of this study is to find out what the correct dose of RO5185426 should be in this age group, and to see how their bodies handle the drug (pharmacokinetics). The study will also see if the drug causes side effects and if it can help stop the growth and spread of the cancer cells in these patients.Researchers have found that a large number of melanomas, as well as other tumours, have mutations (changes) in a gene called the BRAF gene. Genes are a specific part of DNA that contain information on hereditary characteristics such as hair colour and eye colour. The BRAF gene makes a protein called BRAF, which is involved in sending signals within cells for cell growth. Certain mutations in the BRAF gene cause a change in the BRAF protein that can increase the growth and spread of cancer cells. RO5185426 works by preventing these altered BRAF proteins from working, thereby blocking the growth and spread of the cancer cells.Approximately 20-30 patients with melanoma whose tumours have a mutation in the BRAF gene from 15??20 sites in approximately six countries will take part in this study.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/1490

• Date of REC Opinion

  14 Oct 2011

• REC opinion

  Favourable Opinion