Clinical trial NCT00387205: Study To Assess Long Term Safety Of Pazopanib
Official title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Renal Cell
Keywords: chronic administration
monotherapy and combination therapies
solid
lapatinib (TYKERB, TYVERB)
malignant tumor
Pazopanib
GW786034
cancer
safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Aurora
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Lebanon
country: United States
facility: Novartis Investigative Site
state: New Hampshire
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Lyon Cedex 08
country: France
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: