Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00277316
• Other study ID #: XL999-201
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: February 18, 2010
• Start date: December 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• XL999
Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	The Cleveland Clinic Foundation Taussig Cancer Center	Cleveland	Ohio
United States	Center for Oncology Research and Treatment, PA	Dallas	Texas
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Division of Hematology/Oncology, Indiana University Cancer Center	Indianapolis	Indiana
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Ltd	Joliet	Illinois
United States	Department of Hematology/Oncology	Los Angeles	California
United States	Stanford Cancer Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Inclusion until disease progression	No
Primary	Safety and tolerability		Inclusion until 30 days post last treatment	Yes
Secondary	Progression-free survival		Inclusion until disease progression	No
Secondary	Duration of response		Inclusion until disease progression	No
Secondary	Overall survival		Inclusion until 180-day Follow-up post last treatment or death	No
Secondary	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.	Yes