NCT01060514

Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.

Detailed description

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.

Conditions

• Metastatic Non Small Cell Lung Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Pazopanib	dose escalation, administered orally, daily
DRUG	Vinorelbine	dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2013-09-01
• First posted: 2010-02-02
• Last updated: 2013-10-30

Locations

1 site across 1 country: United States