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

Breast Neoplasm Clinical Trial

— CHIVE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01596530
• Other study ID #: D0102C00019
• Status: Terminated
• Phase: Phase 1
• First received: April 27, 2012
• Last updated: December 13, 2012
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of HealthFrance: Ministry of HealthTaiwan: Department of HealthKorea: Food and Drug AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• Drug-AZD8931
Active drug for biological activity
• Drug-Placebo
Placebo comparator for biological activity comparison

Locations

Country	Name	City	State
Germany	Research Site	Dusseldorf
Germany	Research Site	Essen
Germany	Research Site	Wittenberg
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Yonsei
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment		Day 7 - Day 14	Yes
Secondary	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	No
Secondary	Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study.		From study entry through to 30 days post treatment (Day 44 maximum)	No
Secondary	Assessment of the plasma PK of AZD8931		Day 1 - Day 14	No
Secondary	Comparison of the effects of AZD8931 versus placebo on other biomarkers including but not limited to, erbB ligands, pER, PTEN, erbB receptor homo- and hetero- dimers, total MAPK, apoptosis markers and total AKT after 7 or more days of treatment.		Day 7 - Day 14	Yes
Secondary	Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status		Day -28 to Day 0	No
Secondary	Exploration of the relationship between AZD8931 exposure (PK in plasma and tumour) and a selection of secondary biomarkers (e.g. p-EGFR, nuclear p-MAPK, Ki67 and apoptosis markers after ?7 days of treatment), if possible.		Day 1 - Day 14	No
Secondary	Change from baseline in laboratory, vitals signs and ECG data		Day 1 - Day 14	No