A Two-way Crossover Study Of The Effect Of Food On The Ph... | NCT00363194

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

NCT00363194

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Carcinoma, Renal Cell

Interventions

Pazopanib (GW786034)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2006Actual

Primary Completion Date

Jun 19, 2009Actual

Completion Date

Jun 19, 2009Actual

First Submitted Date

Aug 11, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2017

Last Update Posted Date

Nov 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Label	Type	Description	Intervention Names
Lead-In cohort	Experimental	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)

Name	Type	Description	Arm Group Labels	Other Names
Pazopanib (GW786034)	Drug	Pazopanib (GW786034)	Lead-In cohort

Measure	Description	Time Frame
PK parameters: Cmax, tmax, and AUC		Day 1 and Day 15

Measure	Description	Time Frame
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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Indianapolis	Indiana	46202	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20980999	Background	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.
21811833

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type