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Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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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 CenterMaywood, Illinois  60153