Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.

This study is currently recruiting participants.

Verified by GlaxoSmithKline, January 2009

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00516672

Purpose

This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.

Condition	Intervention	Phase
Solid Tumor Cancer	Drug: pazopanib oral tablets Drug: lapatinib oral tablets	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Lapatinib Lapatinib Ditosylate Pazopanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Factorial Assignment, Safety Study
Official Title:	A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

adverse events change in vital signs change in laboratory values [ Time Frame: 9 Weeks ]

Secondary Outcome Measures:

pharmacokinetic parameters AUC(0-24), AUC(0-inf), Cmax, tmax, t1/2 tumor response on every 9 weeks [ Time Frame: 9 Weeks ]

Estimated Enrollment:	36
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Signed informed consent.
Histologically or cytologically confirmed diagnosis of advanced solid tumor.
Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
ECOG performance status of 0 or 1.
Adequate bone marrow reserve and hepato-renal function.
Able to swallow and retain oral medication.
For combo part, left ventricular ejection fraction within normal range or above 50%.

Exclusion criteria:

Prior treatment with pazopanib, and with lapatinib for combo part.
Clinically significant gastrointestinal abnormalities.
Sevier diseases or conditions other than cancer.
Poorly controlled hypertension.
Use of warfarin for therapeutic anticoagulation.
Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part.
Unresolved and/or unstable toxicities
Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516672

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Japan
GSK Investigational Site	Recruiting
Aichi, Japan, 466-8560
GSK Investigational Site	Recruiting
Saitama, Japan, 350-1298

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109693
Study First Received:	August 13, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00516672
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

pazopanib,
lapatinib,
pharmacokinetics,

safety,
Japanese patients,
cancer

Study placed in the following topic categories:

Lapatinib

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009