NCT00277329

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 non-small cell lung cancer (NSCLC). 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
9

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

4 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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

1.7 years

First QC Date

January 12, 2006

Last Update Submit

February 18, 2010

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Inclusion until disease progression

  • Safety and tolerability

    Inclusion until 30 dyas 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

    Various time points during the 8-week Study Treatment Period in the second stage of the study

Interventions

XL999DRUG

• The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity.

Eligibility Criteria

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

You may qualify if:

  • Males and females with histologically confirmed NSCLC
  • Prior treatment with a platinum- or taxane containing regimen
  • Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy)
  • Measurable disease according to Response Criteria for Solid Tumors (RECIST)
  • 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
  • Use of any systemic anticancer therapy within 30 days of XL999 treatment
  • More than 2 prior systemic cytotoxic chemotherapy regimens
  • More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib)
  • Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered \>30 days before study enrollment
  • Uncontrolled and/or intercurrent illness
  • History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
  • Pregnant or breastfeeding females
  • Known HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hematology/Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Hematology-Oncology Associates of Rockland

Nyack, New York, 10960, United States

Location

Center for Oncology Research and Treatment, PA

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Paul Woodard, 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

August 1, 2007

Study Completion

July 1, 2008

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(4)