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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363194
First Posted: August 15, 2006
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Carcinoma, Renal Cell Drug: Pazopanib (GW786034) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PK parameters: Cmax, tmax, and AUC [ Time Frame: Day 1 and Day 15 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Actual Study Start Date: September 21, 2006
Study Completion Date: June 19, 2009
Primary Completion Date: June 19, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lead-In cohort
In 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.
Drug: Pazopanib (GW786034)
Pazopanib (GW786034)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363194


Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363194     History of Changes
Other Study ID Numbers: VEG10005
First Submitted: August 11, 2006
First Posted: August 15, 2006
Last Update Posted: November 15, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
Pazopanib GW786034 Advanced cancer Metastatic cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases