Conditions: Metastatic Uveal Melanoma
Keywords: uveal melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 152
Healthy volunteers: no

Brief summary:
Selumetinib therapy in patients with metastatic uveal melanoma.

Detailed description:
A randomised double-blind study to assess the efficacy of selumetinib (AZD6244, Hyd-Sulfate) in combination with Dacarbazine compared with placebo in combination with Dacarbazine as first systemic therapy in patients with metastatic uveal melanoma (SUMIT)

Arms:
arm 1: selumetinib 75mg twice daily in combination with dacarbazine. arm 2: placebo twice daily in combination with dacarbazine.

Interventions: intervention 1: 75mg selumetinib intervention 2: placebo intervention 3: Dacarbazine
Intervention descriptions: intervention 1: selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle. intervention 2: placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle. intervention 3: dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.

Protocol document: