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

Carcinoma, Renal Cell Clinical Trial

Official title:

A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516672
• Other study ID #: 109693
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2007
• Last updated: November 8, 2017
• Start date: September 10, 2007
• Est. completion date: October 14, 2015

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 14, 2015
• Est. primary completion date: August 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• pazopanib
Pazopanib oral tablet
• Lapatinib
Lapatinib oral tablet

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.	before and after taking the study medications
Secondary	Pharmacokinetics	The pharmacokinetic parameters AUC0-24, AUC0-inf (Day 1 only), Cmax, tmax, and t1/2 of pazopanib and its four metabolites. To determine if target trough plasma concentration of pazopanib of 20,000 ng/ml is achieved.	over a 24 hour period
Secondary	Tumor response	Assessments of tumor response will be obtained every 9 weeks and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).	9 weeks

External Links

•   Results for study 109693 can be found on the GSK Clinical Study Register.