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Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Metastatic Non Small Cell Lung Cancer, Metastatic Breast Cancer

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Trial Information

Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer

This study involves an investigational drug called pazopanib in combination with the
chemotherapy drug vinorelbine. An investigational drug is a drug that has not been approved
by the U.S. Food and Drug Administration (FDA) for use in the United States. Vinorelbine has
been FDA approved to treat patients with NSCLC and breast cancer. Pazopanib is a vascular
endothelial growth factor inhibitor, which means it may prevent the tumor from growing its
own blood vessels thereby interfering with the growth of the tumor. Participants in this
study will be assigned to one of three groups with each group receiving a higher dose of
vinorelbine and pazopanib than the previous group. Vinorelbine will be given through a
needle in the vein on days 1 and 8 of each 21 day study treatment cycle. Pazopanib is a pill
which will be taken by mouth every day during the 21 day study treatment cycle.

Inclusion Criteria:

- Age > 18 years

- Patients must have diagnosis of breast cancer or non small cell lung cancer

- Patients must have evaluable disease

- Women of childbearing potential and sexually active males must commit to the use of
effective contraception while on study.

- Patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

- Patients must not be pregnant and/or lactating.

- Patients must not be receiving any other investigational agents.

- No prior exposure to vinorelbine or other VEGF inhibitors as treatment for
metastatic disease

- Patients must not have received prior therapy (including radiation, surgery, and/or
chemotherapy) within 30 days

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to pazopanib or vinorelbine.

- Patients cannot have received more than 2 prior chemotherapy regimens for lung cancer
or 3 prior chemotherapy regimens for breast cancer. This criterion can be discussed
further with the study doctor.

- Must not have uncontrolled illness including, but not limited to: ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmic, psychiatric illness/social situations that would limit compliance with
study requirements.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.

Outcome Time Frame:

at study completion (estimated at 2 years)

Safety Issue:


Principal Investigator

Jyoti D Patel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 09L1



Start Date:

February 2010

Completion Date:

February 2015

Related Keywords:

  • Metastatic Non Small Cell Lung Cancer
  • Metastatic Breast Cancer
  • Lung cancer
  • Breast cancer
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Northwestern University, Northwestern Medical Faculty FoundationChicago, Illinois  60611-3013