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

NCT01596530 | Terminated Phase 1

• 1 other identifier: D0102C00019
• Study Type: interventional
• Target: 3
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Breast Neoplasm

Keywords

Breast Neoplasm; Breast Cancer; Breast Tumour; Cancer of Breast; Cancer of the Breast

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• 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.

  From study entry through to 30 days post treatment (Day 44 maximum)

• Assessment of the plasma PK of AZD8931

  Day 1 - Day 14

• 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

• Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status

  Day -28 to Day 0

Study Arms (2)

AZD8931

ACTIVE COMPARATOR

AZD8931

Drug: Drug-AZD8931

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Drug-Placebo

Interventions

Drug-AZD8931 DRUG

Active drug for biological activity

AZD8931

Drug-Placebo DRUG

Placebo comparator for biological activity comparison

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Düsseldorf, Germany

Location

Research Site

Essen, Germany

Location

Research Site

Wittenberg, Germany

Location

Research Site

Seoul, South Korea

Location

Research Site

Yonsei, South Korea

Location

Research Site

Taichung, Taiwan

Location

Research Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Serban Ghiorghiu, M.D.

  Internal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 11, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

TW (2); DE (3); KR (2)