A Phase 1b Trial in Patients With Renal Cell Cancer
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.
Metastatic Renal Cell Cancer
Drug: Drug: LY573636-sodium
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer|
- Recommended dose for Phase 2 studies of LY573636-sodium combined with Sunitinib in patients with metastatic Renal Cell Carcinoma [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
- Pharmacokinetics, concentration maximum (Cmax) for LY573636-sodium [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
- Number of participants with tumor responses [ Time Frame: Baseline through study completion ] [ Designated as safety issue: No ]
- Sunitinib pharmacokinetics in the presence of LY573636, area under the curve (AUC) [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
- Pharmacokinetics, area under the curve (AUC) for LY573636-sodium [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
- The number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: LY573636 +sunitinib||
Drug: Drug: LY573636-sodium
Patient 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 patients enrolled after MTD will receive albumin-tailored doses.
Patients may continue on treatment until clinical or objective disease progression.
Other Name: TasisulamDrug: Sunitinib
37.5 mg, administered orally, daily for 42 days (6 weeks). Patients may continue on treatment until clinical or objective disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258348
|United States, Indiana|
|Indianapolis, Indiana, United States, 46219|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29605|
|United States, Texas|
|The Woodlands, Texas, United States, 77380|
|United States, Virginia|
|Norfolk, Virginia, United States, 23502|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|