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

This study has been terminated.
(All AstraZeneca sponsored clinical trials of AZD8931 have been halted)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01596530
First received: April 27, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Neoplasm
 Drug: Drug-AZD8931
Drug: Drug-Placebo
 Phase 1

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

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment [ Time Frame: Day 7 - Day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Day 7 - Day 14 ] [ Designated as safety issue: No ]
  • Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study. [ Time Frame: From study entry through to 30 days post treatment (Day 44 maximum) ] [ Designated as safety issue: No ]
  • Assessment of the plasma PK of AZD8931 [ Time Frame: Day 1 - Day 14 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Day 7 - Day 14 ] [ Designated as safety issue: Yes ]
  • Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status [ Time Frame: Day -28 to Day 0 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Day 1 - Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in laboratory, vitals signs and ECG data [ Time Frame: Day 1 - Day 14 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AZD8931
AZD8931
 Drug: Drug-AZD8931
Active drug for biological activity
Placebo Comparator: Placebo
Placebo
 Drug: Drug-Placebo
Placebo comparator for biological activity comparison

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596530

Locations
Germany
Research Site
Dusseldorf, Germany
Research Site
Essen, Germany
Research Site
Wittenberg, Germany
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Yonsei, Korea, Republic of
Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Serban Ghiorghiu, M.D. Internal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01596530     History of Changes
Other Study ID Numbers: D0102C00019
Study First Received: April 27, 2012
Last Updated: December 13, 2012
Health Authority: Germany: Ministry of Health
France: Ministry of Health
Taiwan: Department of Health
Korea: Food and Drug Administration
Poland: Ministry of Health

Keywords provided by AstraZeneca:
Breast Neoplasm
Breast Cancer
Breast Tumour
Cancer of Breast
Cancer of the Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013