Evaluation of Drug Activity in Women With Breast Cancer a... | NCT01596530

Studies
Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment

NCT01596530

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Dec 17, 2012Estimated

Enrollment

3Actual

Phase

Phase 1

Conditions

Breast Neoplasm

Interventions

Drug-AZD8931
Drug-Placebo

Countries

Germany
South Korea
Taiwan

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

All AstraZeneca sponsored clinical trials of AZD8931 have been halted

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Apr 27, 2012

First Submission Date that Met QC Criteria

May 9, 2012

First Posted Date

May 11, 2012Estimated

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

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Description Module

Brief Summary

To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours

Detailed Description

A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD8931	Active Comparator	AZD8931	Drug: Drug-AZD8931
Placebo	Placebo Comparator	Placebo	Drug: Drug-Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug-AZD8931	Drug	Active drug for biological activity	AZD8931
Drug-Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment		Day 7 - Day 14

Secondary Outcomes

Measure	Description	Time Frame
Comparison of the effects of AZD8931 versus placebo on p-EGFR, p-erbB2, p-erbB3 NUCLEAR p-Mapk, p-AKT and Ki67 after 7 or more days of treatment		Day 7 - Day 14
Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females aged 18 or older Early stage breast cancer and planned surgery
Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.

Exclusion Criteria:

Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6

Accepts Healthy Volunteers

Sex

Female

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
Serban Ghiorghiu, M.D.	Internal	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Düsseldorf			Germany
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided