Study of XL999 in Patients With Metastatic Renal Cell Carcinoma - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00277316

Purpose

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.

Condition	Intervention	Phase
Renal Cell Carcinoma	Drug: XL999	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma

Further study details as provided by Exelixis:

Primary Outcome Measures:

Response rate
Safety and tolerability

Secondary Outcome Measures:

Progression-free survival
Duration of response
Overall survival
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters

Estimated Enrollment:	72
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277316

Locations

United States, California

Los Angeles, California, United States, 90085

Palo Alto, California, United States, 94305
United States, Florida

Jacksonville, Florida, United States, 32256
United States, Illinois

Chicago, Illinois, United States, 60637

Joliet, Illinois, United States, 60435
United States, Indiana

Indianapolis, Indiana, United States, 46202
United States, New York

New York, New York, United States, 10021
United States, Ohio

Cleveland, Ohio, United States, 44195
United States, Texas

Dallas, Texas, United States, 75230

Fort Worth, Texas, United States, 76104

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Exelixis

More Information

Study ID Numbers:	XL999-201
Study First Received:	January 12, 2006
Last Updated:	June 26, 2007
ClinicalTrials.gov Identifier:	NCT00277316
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

Kidney cancer
Metastatic

Study placed in the following topic categories:

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases

Kidney cancer
Urologic Neoplasms
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009