Study of E7080 in two groups of previously treated melanoma patients

• Research type

  Research Study

• Full title

  An Open Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

• IRAS ID

  62593

• Contact name

  Jeff Evans

• Sponsor organisation

  Eisai Ltd

• Eudract number

  2010-019526-14

• Clinicaltrials.gov Identifier

  NCT01136967

• Research summary

  Advanced melanoma is an aggressive incurable form of cancer with an average survival of 7-10 months. Limited therapeutic options exist and five-year survival for patients with disseminated (spread) melanoma is 5-10%. The main purpose of this open-label study is to determine the effects and safety of a new experimental drug called E7080. E7080 is being developed for cancer treatment including melanoma; it is thought to work by stopping the formation of new blood vessels that help cancer cells grow and spread. Patients with melanoma often have a defect or mutation in the BRAF gene in their tumour cells. We do not know if melanomas with or without this mutation will respond differently to E7080. This study will measure the effects of the drug (taken orally once daily) in 2 groups of participants: those with and without the mutation. 180 participants will be recruited (90 in each group); the study will take 60 months to complete, however, most participants are expected to take study treatment for about 8 months. All participants will receive the study drug.The study comprises 3 phases: a Pre-treatment Phase, a Treatment Cycle Phase and an Extension Phase. Every treatment ??Cycle? is 28 days, there are study visits on days 1 and 15 of each cycle. Tests to be performed during study visits include: physical examinations, ECGs and blood and urine samples. Every 8 weeks tumour tests will be done to determine whether any shrinkage has occurred and to see how long any effect on the tumour lasts. These will include CT scans or MRIs, X-rays of chest, abdomen, pelvis, brain and other areas if needed, and digital photographs of skin tumours. Bone scans will be done every 6 cycles.This study, sponsored by Eisai, will be performed at approximately 60 sites worldwide.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/75

• Date of REC Opinion

  1 Nov 2010

• REC opinion

  Favourable Opinion