Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

Phase 2

Terminated

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT00277316
• Lead Sponsor: Symphony Evolution, Inc.

Brief Summary

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell carcinoma (RCC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-16
• Primary Completion: 2007-02
• Study Completion: 2007-06
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Males and females with histologically confirmed metastatic clear cell RCC
• Measurable disease according to Response Criteria for Solid Tumors (RECIST)
• No prior systemic cytotoxic chemotherapy
• Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
• ECOG performance status of 0 or 1
• Life expectancy ≥3 months
• Adequate organ and marrow function
• No other malignancies within 5 years
• Signed informed consent

Exclusion Criteria

• Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
• Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
• Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered >30 days prior to study enrollment
• History of or known brain metastases, current spinal cord compression or carcinomatous meningitis
• Uncontrolled and/or intercurrent illness
• Pregnant or breastfeeding females
• Known HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	Inclusion until disease progression
Safety and tolerability	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Inclusion until disease progression
Duration of response	Inclusion until disease progression
Overall survival	Inclusion until 180-day Follow-up post last treatment or death
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters	Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.

Trial Locations

Locations (9)

Joliet Oncology-Hematology Associates, Ltd; 🇺🇸 Joliet, Illinois, United States

Division of Hematology/Oncology, Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

Department of Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

Integrated Community Oncology Network; 🇺🇸 Jacksonville, Florida, United States

The Cleveland Clinic Foundation Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States

The Center for Cancer and Blood Disorders; 🇺🇸 Fort Worth, Texas, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Center for Oncology Research and Treatment, PA; 🇺🇸 Dallas, Texas, United States