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Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XL999
Sponsored by
Symphony Evolution, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney cancer, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hematology/Oncology
  • Stanford Cancer Center
  • Integrated Community Oncology Network
  • University of Chicago
  • Joliet Oncology-Hematology Associates, Ltd
  • Division of Hematology/Oncology, Indiana University Cancer Center
  • The Cleveland Clinic Foundation Taussig Cancer Center
  • Center for Oncology Research and Treatment, PA
  • The Center for Cancer and Blood Disorders

Outcomes

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

Full Information

First Posted
January 12, 2006
Last Updated
February 18, 2010
Sponsor
Symphony Evolution, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00277316
Brief Title
Study of XL999 in Patients With Metastatic Renal Cell Carcinoma
Official Title
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Development of XL999 was stopped due to cardiac toxicities in the subjects
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Symphony Evolution, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Kidney cancer, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
XL999
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Inclusion until disease progression
Title
Safety and tolerability
Time Frame
Inclusion until 30 days post last treatment
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Inclusion until disease progression
Title
Duration of response
Time Frame
Inclusion until disease progression
Title
Overall survival
Time Frame
Inclusion until 180-day Follow-up post last treatment or death
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne A. Bui, MD
Organizational Affiliation
Exelixis
Official's Role
Study Director
Facility Information:
Facility Name
Department of Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Division of Hematology/Oncology, Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Cleveland Clinic Foundation Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Center for Oncology Research and Treatment, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

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