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Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)

NCT00900627 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2016-01-20

Study results available
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Summary

The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

Conditions

Interventions

DRUG

AZD8931

Tablet Oral bid

DRUG

Paclitaxel

IV once weekly for 3 weeks followed by a week off (repeated cycles)

DRUG

Placebo

Oral bid (twice daily)

Sponsors & Collaborators

Principal Investigators

  • Dr Serban Ghiorghiu · AstraZeneca

  • Professor Jose Baselga · Vall d'Hebron University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
150 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-04-30
Completion
2015-02-28

Countries

  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Hungary
  • Italy
  • Panama
  • Peru
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00900627 on ClinicalTrials.gov