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

NCT00707707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-03-06

No results posted yet for this study

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

Interventions

DRUG

AZD2281

Dose finding study to establish the appropriate dose of AZD2281

DRUG

Paclitaxel

Intravenous infusion over 1 hour

Sponsors & Collaborators

Principal Investigators

  • Rebecca Dent, MD · Sunnybrook Health Sciences Centre, Toronto

  • Mark Clemons, MD · Princess Margaret Hospital, Toronto

  • Mika Sovak, MD PhD · AstraZeneca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-15
Primary Completion
2009-11-09
Completion
2018-02-19

Countries

  • Australia
  • Austria
  • Belgium
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707707 on ClinicalTrials.gov