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

NCT ID: NCT00707707

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-15
• Study Completion Date: 2018-02-19

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.

Conditions

Breast Cancer; Triple Negative Breast Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

paclitaxel + AZD2281

Group Type: EXPERIMENTAL

AZD2281

Intervention Type: DRUG

Dose finding study to establish the appropriate dose of AZD2281

Paclitaxel

Intervention Type: DRUG

Intravenous infusion over 1 hour

Interventions

AZD2281

Dose finding study to establish the appropriate dose of AZD2281

Intervention Type: DRUG

Paclitaxel

Intravenous infusion over 1 hour

Intervention Type: DRUG

Other Intervention Names

Olaparib; Taxol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Dent, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, Toronto

Mark Clemons, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Toronto

Mika Sovak, MD PhD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Auchenflower, , Australia

Research Site

Parkville, , Australia

Research Site

Perth, , Australia

Research Site

Vienna, , Austria

Research Site

Leuven, , Belgium

Research Site

Toronto, Ontario, Canada

Countries

Australia; Austria; Belgium; Canada

References

Dent RA, Lindeman GJ, Clemons M, Wildiers H, Chan A, McCarthy NJ, Singer CF, Lowe ES, Watkins CL, Carmichael J. Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2013;15(5):R88. doi: 10.1186/bcr3484.

Reference Type: DERIVED

PMID: 24063698 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1673&filename=D0810C00011.pdf

D0810C00011\_CSR\_Synopsis

Other Identifiers

D0810C00011

Identifier Type: -

Identifier Source: org_study_id