NCT00387205

Brief Summary

This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
4 countries

19 active sites

Status
completed

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

Study Start

First participant enrolled

June 20, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2013

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

6.7 years

First QC Date

October 10, 2006

Last Update Submit

March 4, 2019

Conditions

Carcinoma, Renal Cell

Keywords

chronic administrationmonotherapy and combination therapiessolidlapatinib (TYKERB, TYVERB)malignant tumorPazopanibGW786034cancersafety

Outcome Measures

Primary Outcomes (1)

  • To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors

    To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.

    Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.

Study Arms (1)

Arm 1

EXPERIMENTAL

Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Drug: Pazopanib

Interventions

PazopanibDRUG

Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
  • Able to understand and provide written informed consent
  • Women and men agree to use protocol specific birth control measures

You may not qualify if:

  • The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
  • If you are pregnant or breast feeding
  • Your doctor does not think you would be a good candidate for the study
  • Poorly controlled high blood pressure
  • Subject is unwilling or unable to follow the procedures outlined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Novartis Investigative Site

Duarte, California, 91010, United States

Location

Novartis Investigative Site

Santa Monica, California, 90404, United States

Location

Novartis Investigative Site

Aurora, Colorado, 80045, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46202, United States

Location

Novartis Investigative Site

Detroit, Michigan, 48201, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55404, United States

Location

Novartis Investigative Site

Lebanon, New Hampshire, 03756, United States

Location

Novartis Investigative Site

New Brunswick, New Jersey, 08901, United States

Location

Novartis Investigative Site

Buffalo, New York, 14263, United States

Location

Novartis Investigative Site

Durham, North Carolina, 27710, United States

Location

Novartis Investigative Site

Cleveland, Ohio, 44106, United States

Location

Novartis Investigative Site

Greenville, South Carolina, 29605, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

June 20, 2006

Primary Completion

February 13, 2013

Study Completion

March 8, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)US(15)GB(2)FR(1)