A Phase I Open Label Dose Escalation Study for the Safety... | NCT00503477

Studies
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

NCT00503477

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 12, 2009Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Advanced Solid Tumor

Interventions

AZD2171

Countries

Japan

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

Jun 2009

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

Oct 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jul 16, 2007

First Submission Date that Met QC Criteria

Jul 16, 2007

First Posted Date

Jul 18, 2007Estimated

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

Jun 11, 2009

Last Update Posted Date

Jun 12, 2009Estimated

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

A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients

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

40Actual

Name	Type	Description	Arm Group Labels	Other Names
AZD2171	Drug	oral tablet		cediranib RECENTIN™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability		Assessed at each visit for 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
efficacy, PK		Assessed at each visit for 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

advanced solid tumors
life expectancy is 12 weeks or longer

Exclusion Criteria:

patient with uncontrolled brain metastases
patient with inappropriate laboratory test values
patient with poorly controlled hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jane Robertson	AstraZeneca	Study Director
Tomohide Tamura, MD	National Cancer Centre Hospital, Tokyo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Shizuoka			Japan
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
C500926	cediranib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided