Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

This study has been terminated.
(Development of XL999 was stopped due to cardiac toxicities in the subjects)
Information provided by:
Symphony Evolution, Inc. Identifier:
First received: January 12, 2006
Last updated: February 18, 2010
Last verified: February 2010

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • Response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Inclusion until 180-day Follow-up post last treatment or death ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters [ Time Frame: Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment. ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: December 2005
Study Completion Date: June 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00277316

United States, California
Department of Hematology/Oncology
Los Angeles, California, United States, 90095
Stanford Cancer Center
Palo Alto, California, United States, 94305
United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois, United States, 60435
United States, Indiana
Division of Hematology/Oncology, Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Ohio
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Texas
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States, 75230
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Symphony Evolution, Inc.
Study Director: Lynne A. Bui, MD Exelixis, Inc
  More Information

No publications provided

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc. Identifier: NCT00277316     History of Changes
Other Study ID Numbers: XL999-201
Study First Received: January 12, 2006
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Symphony Evolution, Inc.:
Kidney cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on November 20, 2014