Phase I/II AZD2281/Cisplatin in Neoadjuvant Treatment of Triple Negative Breast Cancer Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00782574

Purpose

This is the first part of a 2-part study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid tumours. This first part (Phase I) is open-label dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. The second part (Phase II) is randomised; to assess the efficacy in neoadjuvant setting triple negative breast cancer patients. Approximately 18 patients from 2 countries will be enrolled in Phase I and 120 patients from 2 countries will be enrolled in Phase II.

Condition	Intervention	Phase
Advanced Solid Tumors Triple Negative Breast Cancer	Drug: AZD2281 Drug: Cisplatin	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cisplatin AZD 2281

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase I/II, Open Label, Multi-Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours, and to Assess Efficacy in the Neoadjuvant Setting for Patients With Triple Negative Breast Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Phase I/Part A: To determine the safety and tolerability of AZD2281 in combination with cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours [ Time Frame: Weekly visits for routine monitoring visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase I/Part A: To compare exposure to AZD2281 when given alone and in combination with cisplatin [ Time Frame: PK samples taken at visit 2 and 3 ] [ Designated as safety issue: No ]
Part A: To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with cisplatin, by measuring overall objective response rate [ Time Frame: Assessed at screening, visit 9, and at end of every 2 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD2281 + Cisplatin combination therapy	Drug: AZD2281 Capsule Oral bid Drug: Cisplatin IV every 3 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Life expectancy of at least 12 weeks
Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
Patients with measurable or non measurable disease according to RECIST

Exclusion Criteria:

Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy
Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for >1 week
Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782574

Contacts

Contact: AstraZeneca Study Information (outside US)	8100-236-9933	information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com

Locations

United States, Massachusetts
Research Site	Recruiting
Boston, Massachusetts, United States
Spain
Research Site	Recruiting
Barcelona, Spain

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	James Carmichael, BSc, MBCHB, MD, FRCP	AstraZeneca
Principal Investigator:	Judy E Garber	Dana-Farber Cancer Institute
Principal Investigator:	J Ballmana Gelpi	Vall d'Hebron

More Information

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( James Carmichael, MD, Medical Science Director, AstraZeneca )
Study ID Numbers:	D0810C00021
Study First Received:	October 29, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00782574 History of Changes
Health Authority:	Spain: Ministry of Health; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

breast cancer
Poly(ADP ribose) polymerases
homologous deficiency
BRCA1
Breast Neoadjuvant

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009