Last updated: 11/04/2018 13:08:49
A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
PK parameters: Cmax, tmax, and AUC
Timeframe: 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
Timeframe: 14 weeks
Interventions:
Drug: Pazopanib (GW786034)
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Heath EI, Chiorean EG, Sweeney C, Hodge JP, Lager JJ, Forman K, Malburg L, Arumugham T, Dar MM, Suttle AB, Gainer S, LoRusso P. A Phase I Study of the Pharmacokinetic and Safety Profile of Oral Pazopanib Dosing With a High-Fat or Low-Fat Meal in Patients With Advanced Solid Tumors . [Clin Pharmacol Ther]. 2010;88(6):818-823.
Heath 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;4(Aug 30):1566-74.
Heath EI, Chiorean EG, Sweeney C, Hodge JP, Lager JJ, Forman K, Malburg L, Arumugham T, Dar MM, Suttle AB, Gainer S, LoRusso P. A Phase I Study of the Pharmacokinetic and Safety Profile of Oral Pazopanib Dosing With a High-Fat or Low-Fat Meal in Patients With Advanced Solid Tumors . [Clin Pharmacol Ther]. 2010;88(6):818-823
Heath EI, Chiorean EG, Sweeney C, et al. A Phase I Study of the Pharmacokinetic and Safety Profile of Oral Pazopanib Dosing With a High-Fat or Low-Fat Meal in Patients With Advanced Solid Tumors. Clin Pharmacol Ther. 2010;88(6):818-823
Heath 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;4(Aug 30):1566-74
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
September 2006 to June 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
21+ years
Accepts healthy volunteers
No
- 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.
- Patients with certain heart problems or history of bleeding within a month.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-19-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study VEG10005 can be found on the GSK Clinical Study Register.
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