A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.
Phase 1
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Carcinoma, Renal Cell
Both
Carcinoma, Renal Cell
Trial Information
A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability
Outcome Description:
The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.
Outcome Time Frame:
before and after taking the study medications
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
109693
NCT ID:
NCT00516672
Start Date:
September 2007
Completion Date:
November 2013
Related Keywords:
- Carcinoma, Renal Cell
- lapatinib,
- cancer
- pharmacokinetics,
- safety,
- pazopanib,
- Japanese patients,
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|
