Clinical trial NCT00277329: Study of XL999 in Patients With Non-small Cell Lung Cancer
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: Inclusion until disease progression
measure: Safety and tolerability
timeFrame: Inclusion until 30 dyas post last treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: Inclusion until disease progression
measure: Duration of response
timeFrame: Inclusion until disease progression
measure: Overall survival
timeFrame: Inclusion until 180-Day Follow-up post last treatment or death
measure: Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
timeFrame: Various time points during the 8-week Study Treatment Period in the second stage of the study
Other outcomes:
Locations:
city: Port St. Lucie
country: United States
facility: Hematology/Oncology Associates of the Treasure Coast
state: Florida
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Nyack
country: United States
facility: Hematology-Oncology Associates of Rockland
state: New York
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
Study officials:
affiliation: Exelixis
name: Paul Woodard, MD
role: STUDY_DIRECTOR
References: