Study With Improved Solubility Pazopanib | NCT02810756

Studies
Study With Improved Solubility Pazopanib

NCT02810756

Sponsor

The Netherlands Cancer Institute

Status

Completed

Last Update Posted

Sep 11, 2017Actual

Enrollment

12Actual

Phase

Early Phase 1

Conditions

Pharmacokinetics of Pazopanib

Interventions

New Pazopanib formulation

Countries

Netherlands

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

Sep 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 15, 2016Actual

Primary Completion Date

Aug 28, 2017Actual

Completion Date

Aug 28, 2017Actual

First Submitted Date

May 31, 2016

First Submission Date that Met QC Criteria

Jun 20, 2016

First Posted Date

Jun 23, 2016Estimated

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

Sep 8, 2017

Last Update Posted Date

Sep 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Treated patients	Experimental		Drug: New Pazopanib formulation

Name	Type	Description	Arm Group Labels	Other Names
New Pazopanib formulation	Drug		Treated patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration	Concentration of pazopanib in plasma	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 week
Area under the plasma concentration versus time curve (AUC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Locally advanced or metastatic cancer;
Able and willing to give written consent;
WHO performance status of 0, 1 or 2;
Able and willing to undergo blood sampling for PK analysis;
Minimal acceptable safety laboratory values;
Negative pregnancy test for female patients with childbearing potential;
Able and willing to swallow oral medication.

Exclusion Criteria:

Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;
Any treatment with CYP3A4, BCRP or PGP interfering drugs;
Patients who received treatment with Votrient(R) kess than 1 week ago;
Woman who are pregnant or breast feeding;
Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Netherlands Cancer Institute		Amsterdam	North Holland	1066 CX	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will remain confidential

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided