Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00707707

Collaborator

(none)

Enrollment

Locations

Arm

113.1

Actual Duration (Months)

3.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Triple Negative Breast Cancer Metastatic Breast Cancer	Drug: AZD2281 Drug: Paclitaxel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Randomised, Double- Blind, Multi-centre Study to Assess the Efficacy of AZD2281 When Given in Combination With Paclitaxel in the 1st or 2nd Line Treatment of Patients With Metastatic Triple Negative Breast Cancer.

Actual Study Start Date :

Sep 15, 2008

Actual Primary Completion Date :

Nov 9, 2009

Actual Study Completion Date :

Feb 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 paclitaxel + AZD2281	Drug: AZD2281 Dose finding study to establish the appropriate dose of AZD2281 Other Names: Olaparib Drug: Paclitaxel Intravenous infusion over 1 hour Other Names: Taxol

Arm

Intervention/Treatment

Experimental: 1

paclitaxel + AZD2281

Drug: AZD2281

Dose finding study to establish the appropriate dose of AZD2281

Other Names:

Olaparib

Drug: Paclitaxel

Intravenous infusion over 1 hour

Other Names:

Taxol

Outcome Measures

Primary Outcome Measures

Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis [Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with histologically or cytologically diagnosed metastatic triple negative breast cancer (Oestrogen, progesterone and HER2 negative adenocarcinoma of the breast)
Patients must have normal organ and bone marrow function, ECOG performance status of no more than 2
Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria:

Any chemotherapy, radiotherapy (except for palliative reasons) or investigational product, within 2 weeks from the last dose prior to study entry (or longer period, depending on the agent used)
Major surgery within 4 weeks of starting the study, and must have recovered from any effects of major surgery
Patients requiring treatment with the following:certain antibiotic drugs, St.John's Wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/ non-nucleoside reverse transcriptase inhibitors used as components of HIV/AIDS treatment,
Patients with second primary cancer; except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for at least 5 years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Auchenflower		Australia	4066
2	Research Site	Parkville		Australia	3050
3	Research Site	Perth		Australia	6000
4	Research Site	Wien		Austria	1090
5	Research Site	Leuven		Belgium	3000
6	Research Site	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Rebecca Dent, MD, Sunnybrook Health Sciences Centre, Toronto
Principal Investigator: Mark Clemons, MD, Princess Margaret Hospital, Toronto
Study Director: Mika Sovak, MD PhD, AstraZeneca