CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Drug: LY573636-sodium +1 moredrug
Likely dose
Sunitinib 50 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01258348
NCT01258348Phase 1Completed
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A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer

Eli Lilly and Company·interventional·Posted Dec 10, 2010·Updated Jan 10, 2019

In Brief

A Phase 1 clinical trial evaluating Drug: LY573636-sodium and Sunitinib for Metastatic Renal Cell Cancer. Completed, enrolled 21 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Renal Cell Cancer
CountriesCanada, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2010
Enrollment StartJul 1, 2008
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.6 years ago

Interventions

Drug: LY573636-sodiumdrug

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.

Sunitinibdrug

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.