Study of XL999 in Patients With Non-small Cell Lung Cancer
This study has been terminated.
(Study was terminated due to cardiac toxicities in the subejcts)
Sponsor:
Symphony Evolution, Inc.
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00277329
First received: January 12, 2006
Last updated: February 18, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: XL999 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Symphony Evolution, Inc.:
Primary Outcome Measures:
- Response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: Inclusion until 30 dyas post last treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Inclusion until 180-Day Follow-up post last treatment or death ] [ Designated as safety issue: No ]
- Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters [ Time Frame: Various time points during the 8-week Study Treatment Period in the second stage of the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 9 |
| Study Start Date: | December 2005 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277329
Locations
| United States, Florida | |
| Hematology/Oncology Associates of the Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| United States, Illinois | |
| Joliet Oncology-Hematology Associates, Ltd. | |
| Joliet, Illinois, United States, 60435 | |
| United States, New York | |
| Hematology-Oncology Associates of Rockland | |
| Nyack, New York, United States, 10960 | |
| United States, Texas | |
| Center for Oncology Research and Treatment, PA | |
| Dallas, Texas, United States, 75230 | |
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
| Study Director: | Paul Woodard, MD | Exelixis, Inc. |
More Information
No publications provided
| Responsible Party: | Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc. |
| ClinicalTrials.gov Identifier: | NCT00277329 History of Changes |
| Other Study ID Numbers: | XL999-204 |
| Study First Received: | January 12, 2006 |
| Last Updated: | February 18, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013