Study of XL999 in Patients With Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00277329
• Other study ID #: XL999-204
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: February 18, 2010
• Start date: December 2005
• Est. completion date: July 2008

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• XL999
• 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.

Locations

Country	Name	City	State
United States	Center for Oncology Research and Treatment, PA	Dallas	Texas
United States	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois
United States	Hematology-Oncology Associates of Rockland	Nyack	New York
United States	Hematology/Oncology Associates of the Treasure Coast	Port St. Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Inclusion until disease progression	No
Primary	Safety and tolerability		Inclusion until 30 dyas post last treatment	Yes
Secondary	Progression-free survival		Inclusion until disease progression	No
Secondary	Duration of response		Inclusion until disease progression	No
Secondary	Overall survival		Inclusion until 180-Day Follow-up post last treatment or death	No
Secondary	Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters		Various time points during the 8-week Study Treatment Period in the second stage of the study	Yes