Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

February 18, 2010 updated by: Symphony Evolution, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Renal Cell Carcinoma

Intervention / Treatment

Drug: XL999

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90095
    - Department of Hematology/Oncology
  - Palo Alto, California, United States, 94305
    - Stanford Cancer Center
- Florida
  - Jacksonville, Florida, United States, 32256
    - Integrated Community Oncology Network
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, LTD
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Division of Hematology/Oncology, Indiana University Cancer Center
- Ohio
  - Cleveland, Ohio, United States, 44195
    - The Cleveland Clinic Foundation Taussig Cancer Center
- Texas
  - Dallas, Texas, United States, 75230
    - Center for Oncology Research and Treatment, PA
  - Fort Worth, Texas, United States, 76104
    - The Center for Cancer and Blood Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate Time Frame: Inclusion until disease progression	Inclusion until disease progression
Safety and tolerability Time Frame: Inclusion until 30 days post last treatment	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival Time Frame: Inclusion until disease progression	Inclusion until disease progression
Duration of response Time Frame: Inclusion until disease progression	Inclusion until disease progression
Overall survival Time Frame: Inclusion until 180-day Follow-up post last treatment or death	Inclusion until 180-day Follow-up post last treatment or death
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.	Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symphony Evolution, Inc.

Investigators

Study Director: Lynne A. Bui, MD, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria