Study To Assess Long Term Safety Of Pazopanib

An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387205

Enrollment

188

Registered

2006-10-12

Start date

2006-06-20

Completion date

2018-03-08

Last updated

2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

chronic administration, monotherapy and combination therapies, solid, lapatinib (TYKERB, TYVERB), malignant tumor, Pazopanib, GW786034, cancer, safety

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.

Interventions

DRUGPazopanib

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

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors	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.	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.

Countries

France, Singapore, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026