NCT00277316

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

1.2 years

First QC Date

January 12, 2006

Last Update Submit

February 18, 2010

Conditions

Renal Cell Carcinoma

Keywords

Kidney cancerMetastatic

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Inclusion until disease progression

  • Safety and tolerability

    Inclusion until 30 days post last treatment

Secondary Outcomes (4)

  • Progression-free survival

    Inclusion until disease progression

  • Duration of response

    Inclusion until disease progression

  • Overall survival

    Inclusion until 180-day Follow-up post last treatment or death

  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters

    Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.

Interventions

XL999DRUG

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Department of Hematology/Oncology

Los Angeles, California, 90095, United States

Location

Stanford Cancer Center

Palo Alto, California, 94305, United States

Location

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Joliet Oncology-Hematology Associates, Ltd

Joliet, Illinois, 60435, United States

Location

Division of Hematology/Oncology, Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

The Cleveland Clinic Foundation Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Center for Oncology Research and Treatment, PA

Dallas, Texas, 75230, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellKidney NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lynne A. Bui, MD

    Exelixis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

December 1, 2005

Primary Completion

February 1, 2007

Study Completion

June 1, 2007

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations

US(9)