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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pazopanib (GW786034)

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Pazopanib GW786034 Advanced cancer Metastatic cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lead-In cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

PK parameters: Cmax, tmax, and AUC

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

Full Information

NCT ID

NCT00363194

First Posted

August 11, 2006

Last Updated

November 13, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00363194

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 21, 2006 (Actual)

Primary Completion Date

June 19, 2009 (Actual)

Study Completion Date

June 19, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

Pazopanib GW786034 Advanced cancer Metastatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lead-In cohort

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Pazopanib (GW786034)

Intervention Description

Pazopanib (GW786034)

Primary Outcome Measure Information:

Title

PK parameters: Cmax, tmax, and AUC

Time Frame

Day 1 and Day 15

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20980999

Citation

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.

Results Reference

background

PubMed Identifier

21811833

Citation

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 Aug;30(4):1566-74. doi: 10.1007/s10637-011-9725-2. Epub 2011 Aug 3.

Results Reference

background

Carcinoma, Renal Cell

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial