Clinical trial NCT00900627: Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Breast Neoplasms
Breast Cancer
Keywords: Cancer
Tumour
Breast cancer
Metastatic
Secondary
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
* Suitable for paclitaxel chemotherapy
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Inadequate kidney, liver, heart, gastric, lung or eye function
* Hypersensitive to paclitaxel
* No symptomatic uncontrolled brain metastases
* Previous taxane chemotherapy within 12 months (Phase II)

Primary outcomes:
measure: Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
timeFrame: Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant
measure: Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
timeFrame: Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
Secondary outcomes:
measure: Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
timeFrame: Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
measure: Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
timeFrame: Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012
Other outcomes:
Locations:
city: Brussels (Jette)
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Vratza
country: Bulgaria
facility: Research Site
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Brno
country: Czech Republic
facility: Research Site
city: Jicin
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 4 - Krc
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Znojmo
country: Czech Republic
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Györ
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Lido di Camaiore
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Treviglio
country: Italy
facility: Research Site
city: Ciudad de Panama
country: Panama
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Dr Serban Ghiorghiu
role: STUDY_DIRECTOR
affiliation: Vall d'Hebron University Hospital
name: Professor Jose Baselga
role: PRINCIPAL_INVESTIGATOR
References: