Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed
malignant pleural effusion) or Stage IV NSCLC.
- ECOG performance status of 0-2
- No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any
other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are
permitted. Palliative radiation therapy must have ended 14 days prior to first dose
of pazopanib. Subject with recurrence after previous NSCLC that has been treated with
surgery with or without adjuvant chemotherapy/radiation for curative intent are
eligible, provided 12 months have passed since this treatment ended.
Exclusion Criteria:
- Appropriate for doublet therapy as first line therapy. At discretion of investigator.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
objective response rate of pazopanib in combination with paclitaxel
Outcome Description:
To evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the RECIST criteria (version 1.1).
Outcome Time Frame:
an average of 2 years
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
202499
NCT ID:
NCT01179269
Start Date:
June 2011
Completion Date:
September 2015
Related Keywords:
- Non Small Cell Lung Cancer
- non small cell lung cancer
- Pazopanib
- Stage IIIB/IV non small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Loyola University Medical Center | Maywood, Illinois 60153 |
