A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients

This is two-part study (Part I/Part II). Part I is designed to determine the effect of a low and high fat meal on the pharmacokinetics of single dose pazopanib (GW572016). Part II is designed to allow patients continued access to study drug in a multiple dosing regimen. Patients who are receiving clinical benefit on that regimen will go into the long term rollover study VEG105430 provided they are stable for 8 weeks.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically or cytologically confirmed diagnosis of advanced solid tumors that have progressed following treatment with standard agents. Patients may have either measurable disease by RECIST or may be followed by a tumor marker for assessment of disease.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate bone marrow function: ANC greater than or equal to 1,500 mm cubed; Platelets count greater than or equal to 100,000 mm cubed; Hgb greater than or equal to 9 g per dL
Adequate renal function as determined by a creatinine clearance greater than 50mL per min calculated by the Cockcroft-Gault Formula; Measured creatinine clearance greater than or equal to 50mL per min by 24-hour urine collection will be acceptable in lieu of a calculated value.
Urine Creatinine Ratio of less than 1 as assessed in a random or spot urine sample.
Adequate hepatic function: total bilirubin less than or equal to 1.5 times the upper limit of normal; AST and ALT less than or equal to 2.5 times the upper limit of normal.
PT, INR, PTT less than or equal to 1.2 times upper limit of normal.
Male or female at least 18 years of age.
A woman is eligible to enter and participate in the study if she is of: Non-childbearing potential; Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception per protocol. A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. If sexually active, patients will continue the recommended contraceptive measures for the duration of the treatment and for 28 days following discontinuation of therapy.
Predicted life expectancy of at least 12 weeks.
Written informed consent.
Able to swallow and retain oral medications.

Exclusion criteria

Patients with certain heart problems or history of bleeding within a month.

Treatment and study plan

Pazopanib (GW786034)

Drug

Pazopanib (GW786034)

Primary outcomes

PK parameters: Cmax, tmax, and AUC

Time frame: Day 1 and Day 15

Secondary outcomes

Safety and tolerability parameters include evaluation of adverse events (AEs), and changes in clinical laboratory, and vital signs assessments under fed and fasted conditions

Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Doses of Pazopanib in Cancer Patients

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Aug 15, 2006
Registry last updated: Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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