Conditions: Metastatic Renal Cell Cancer
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 21
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population. The tumor response rate will also be assessed.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Drug: LY573636-sodium intervention 2: Sunitinib
Intervention descriptions: intervention 1: Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle.

Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses.

Participants may continue on treatment until clinical or objective disease progression. intervention 2: 37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle.

Participants may continue on treatment until clinical or objective disease progression.

Protocol document: