A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients
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
1 other identifier
interventional
28
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2006
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedStudy Start
First participant enrolled
September 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2009
CompletedNovember 17, 2017
November 1, 2017
2.7 years
August 11, 2006
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK parameters: Cmax, tmax, and AUC
Day 1 and Day 15
Secondary Outcomes (1)
Safety and tolerability parameters include evaluation of adverse events (AEs), and changes in clinical laboratory, and vital signs assessments under fed and fasted conditions
14 weeks
Study Arms (1)
Lead-In cohort
EXPERIMENTALIn Part 1 of Lead-In cohort, subjects will be dosed with a single dose of pazopanib with a high-fat breakfast to establish safety and tolerability.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with certain heart problems or history of bleeding within a month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
Related Publications (2)
Heath EI, Chiorean EG, Sweeney CJ, Hodge JP, Lager JJ, Forman K, Malburg L, Arumugham T, Dar MM, Suttle AB, Gainer SD, LoRusso P. A phase I study of the pharmacokinetic and safety profiles of oral pazopanib with a high-fat or low-fat meal in patients with advanced solid tumors. Clin Pharmacol Ther. 2010 Dec;88(6):818-23. doi: 10.1038/clpt.2010.199. Epub 2010 Oct 27.
PMID: 20980999BACKGROUNDHeath EI, Forman K, Malburg L, Gainer S, Suttle AB, Adams L, Ball H, LoRusso P. A phase I pharmacokinetic and safety evaluation of oral pazopanib dosing administered as crushed tablet or oral suspension in patients with advanced solid tumors. Invest New Drugs. 2012 Aug;30(4):1566-74. doi: 10.1007/s10637-011-9725-2. Epub 2011 Aug 3.
PMID: 21811833BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2006
First Posted
August 15, 2006
Study Start
September 21, 2006
Primary Completion
June 19, 2009
Study Completion
June 19, 2009
Last Updated
November 17, 2017
Record last verified: 2017-11