NCT00707707

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1 breast-cancer

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2009

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

March 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

June 27, 2008

Last Update Submit

March 5, 2018

Conditions

Breast CancerTriple Negative Breast CancerMetastatic Breast Cancer

Keywords

breast cancertriple negativemetastatic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL

paclitaxel + AZD2281

Drug: AZD2281Drug: Paclitaxel

Interventions

AZD2281DRUG

Dose finding study to establish the appropriate dose of AZD2281

Also known as: Olaparib
1
PaclitaxelDRUG

Intravenous infusion over 1 hour

Also known as: Taxol
1

Eligibility Criteria

Age18 Years - 130 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Auchenflower, 4066, Australia

Location

Research Site

Parkville, 3050, Australia

Location

Research Site

Perth, 6000, Australia

Location

Research Site

Vienna, 1090, Austria

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 24063698DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast NeoplasmsNeoplasm Metastasis

Interventions

olaparibPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Rebecca Dent, MD

    Sunnybrook Health Sciences Centre, Toronto

    PRINCIPAL INVESTIGATOR

  • Mark Clemons, MD

    Princess Margaret Hospital, Toronto

    PRINCIPAL INVESTIGATOR

  • Mika Sovak, MD PhD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 1, 2008

Study Start

September 15, 2008

Primary Completion

November 9, 2009

Study Completion

February 19, 2018

Last Updated

March 6, 2018

Record last verified: 2018-02

Locations

BE(1)AU(3)CA(1)