NCT01060514

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

January 29, 2010

Last Update Submit

October 28, 2013

Conditions

Metastatic Non Small Cell Lung CancerMetastatic Breast Cancer

Keywords

Lung cancerBreast cancer

Outcome Measures

Primary Outcomes (1)

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

    at study completion (estimated at 2 years)

Secondary Outcomes (3)

  • To determine the response rate, progression free survival and overall survival in patients with metastatic NSCLC and metastatic breast cancer treated with pazopanib in combination with vinorelbine.

    imaging done every 6 weeks

  • To characterize dose limiting toxicities (DLT).

    labs drawn weekly

  • To determine the pharmacokinetic effect of pazopanib on vinorelbine.

    labs drawn on days 1 and 22

Study Arms (1)

Pazopanib + Vinorelbine

EXPERIMENTAL
Drug: PazopanibDrug: Vinorelbine

Interventions

PazopanibDRUG

dose escalation, administered orally, daily

Pazopanib + Vinorelbine
VinorelbineDRUG

dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)

Also known as: Navelbine
Pazopanib + Vinorelbine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBreast NeoplasmsLung Neoplasms

Interventions

pazopanibVinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Jyoti D Patel, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

September 1, 2013

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

US(1)