CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 330 enrolled
Drug / intervention
AZD8931 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00900627
NCT00900627Phase 2Completed
CompareCT.gov

A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer

AstraZeneca·interventional·Posted May 13, 2009·Updated Jan 20, 2016

In Brief

A Phase 2 clinical trial evaluating AZD8931, Paclitaxel, and 1 other intervention for Neoplasms and 2 related conditions. Completed, enrolled 330 participants across 38 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast Neoplasms, Breast Cancer
CountriesBelgium, Brazil, Bulgaria, Canada, Czechia, France, Hungary, Italy, Panama, Peru, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 13, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2012
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.1 years ago

Interventions

AZD8931drug

Tablet Oral bid

Paclitaxeldrug

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

Placebodrug

Oral bid (twice daily)