AZD1152 in Patients With Advanced Solid Malignancies-Study 1 | NCT00497731

Studies
AZD1152 in Patients With Advanced Solid Malignancies-Study 1

NCT00497731

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Jun 22, 2009Estimated

Enrollment

70Estimated

Phase

Phase 1

Conditions

Solid Tumors

Interventions

AZD1152

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Apr 2009Estimated

First Submitted Date

Jul 5, 2007

First Submission Date that Met QC Criteria

Jul 5, 2007

First Posted Date

Jul 9, 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 19, 2009

Last Update Posted Date

Jun 22, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

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

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.

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

70Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1152	Drug	2-hour continuous intravenous infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability		Assessed at each visit

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics		Assessed at predetermined timepoints after dose administration
Effect on biomarkers		Assessed after treatment
Anti-tumor activity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological confirmation of a solid, malignant tumour
At least measurable or non measurable site of disease as defined by modified RECIST criteria.

Exclusion Criteria:

Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug
Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
Recent major surgery within 4 weeks prior to entry to the study

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

Name	Affiliation	Role
Jan Schellens, MD	NKI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Amsterdam			Netherlands
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
C520647	2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided