A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma

Progression-free Survival

Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

Time frame: from start of treatment until progression or death before progression (median 259 days)

Percentage of Subjects With Progression-free Survival at Specific Time-points

Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

Time frame: from start of treatment until progression or death before progression after 3, 6 and 12 months

Overall Survival

Overall Survival was the number of days from the date that combination treatment started until the date of death.

Time frame: from start of treatment until death (median 259 days)

Duration of Response

Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment.

Time frame: from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)

Duration of Complete Response

Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).

Time frame: from confirmed CR until PD (median 259 days)

Duration of Partial Response

Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).

Time frame: from confirmed PR until PD (median 259 days)

Disease Control (DC)

DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point.

Time frame: after start of treatment, at 6 months and 12 months

Duration of Stable Disease

Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment.

Time frame: from start of therapy to PD, only in non-responders (median 259 days)

Time to Response

Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented.

Time frame: start of therapy to confirmed CR or PR (median 259 days)

Time to Progression

Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD.

Time frame: From start of treatment until progression (median 259 days)