Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:

No

Principal Investigator

Lynne A. Bui, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

XL999-201

NCT ID:

NCT00277316

Start Date:

December 2005

Completion Date:

June 2007

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney cancer
  • Metastatic
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Stanford Cancer CenterStanford, California  94305-5824
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
University of ChicagoChicago, Illinois  60637
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Center for Oncology Research and Treatment, PADallas, Texas  75230
The Cleveland Clinic Foundation Taussig Cancer CenterCleveland, Ohio  44195
Joliet Oncology-Hematology Associates, LtdJoliet, Illinois  60435
Department of Hematology/OncologyLos Angeles, California  90095
Division of Hematology/Oncology, Indiana University Cancer CenterIndianapolis, Indiana  46202