| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01258348 | A Phase 1b Trial in Patients With Renal Cell Cancer | PHASE1 | COMPLETED | 21 | — | — | Jul 1, 2008 | Feb 1, 2012 | Jan 10, 2019 | 5 | United States, Canada |
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.
| Arm | Type | Description |
|---|---|---|
| LY573636 +sunitinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Drug: LY573636-sodium | DRUG | 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. |
| Sunitinib | DRUG | 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. |
Inclusion Criteria: * Participants must have a histologically confirmed diagnosis of metastatic Renal Cell Carcinoma (RCC) * Participants must have received no prior treatment with a cytotoxic-based chemotherapy regimen * Participants must have measurable disease as defined by the Response Evaluati...