NCT01258348

A Phase 1b Trial in Patients With Renal Cell Cancer

A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Drug: LY573636-sodium	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.
DRUG	Sunitinib	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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-12-10
• Last updated: 2019-01-10
• Results posted: 2018-10-16

Locations

5 sites across 2 countries: United States, Canada