RO5185426 in Melanoma, Study NO25026

• Research type

  Research Study

• Full title

  BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving RO5185426 or Dacarbazine.

• IRAS ID

  30979

• Contact name

  James Larkin

• Sponsor organisation

  F. Hoffmann-La Roche Ltd.

• Eudract number

  2009-012293-12

• ISRCTN Number

  xx

• Research summary

  The purpose of this study is to find out if the investigational drug RO5185426 can help stop the growth and spread of cancer cells in patients with metastatic melanoma and to see if the drug causes any side effects. Eligible patients are those with inoperable Stage IIIC or Stage IV metastatic melanoma and have not received any previous chemotherapy or immunotherapy since their diagnosis of metastatic melanoma. Patients will be randomly assigned (by chance, like flipping a coin) to receive either:?½ Arm A: RO5185426 tablets taken twice each day at a dose of 960 mg (4 tablets in the morning and 4 tablets in evening administered at clinic visits and at home in between clinic visits) OR ?½ Arm B: Dacarbazine administered intravenously as infusion at a dose of 1000 mg/m2 on Day 1 of an every 3 week cycle (administered only during clinic visits) Patients will continue on study drug until disease progression, unacceptable side effects, or the patient chooses to withdraw from the study.Approximately 680 people will take part in this study in more than 10 countries.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/123

• Date of REC Opinion

  7 Dec 2009

• REC opinion

  Further Information Favourable Opinion