Conditions: Carcinoma, Renal Cell Kidney Disease Kidney Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib

Detailed description:
Sorafenib to be administered as 28-day cycles.

Sorafenib dose escalation by cycle is:

* Cycle 1: 400 mg BID
* Cycle 2: 600 mg BID
* Cycle 3+: 800 mg BID

Within subject dose escalation and maximum dose is dependent on observed tolerability.

Dose escalation only occurs after acceptable tolerability is demonstrated by subject.

Arms:
arm 1: * Cycle 1: 400 mg BID sorafenib
* Cycle 2: 600 mg BID sorafenib
* Cycle 3+: 800 mg BID sorafenib

Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)

Protocol document: