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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms; Breast Neoplasms; Breast Cancer

Intervention: AZD8931 (Drug); Paclitaxel (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Dr Serban Ghiorghiu, Study Director, Affiliation: AstraZeneca
Professor Jose Baselga, Principal Investigator, Affiliation: Vall d'Hebron University Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel

Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone

Secondary outcome:

Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone

Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Research Site, Brussels (Jette), Belgium

Research Site, Leuven, Belgium

Research Site, Namur, Belgium

Research Site, Sint-Niklaas, Belgium

Research Site, Sao Paulo, Brazil

Research Site, São Paulo, Brazil

Research Site, Sofia, Bulgaria

Research Site, Stara Zagora, Bulgaria

Research Site, Varna, Bulgaria

Research Site, Vratza, Bulgaria

Research Site, Brno, Czech Republic

Research Site, Jicin, Czech Republic

Research Site, Olomouc, Czech Republic

Research Site, Praha 2, Czech Republic

Research Site, Praha 4 - Krc, Czech Republic

Research Site, Praha 4, Czech Republic

Research Site, Znojmo, Czech Republic

Research Site, Villejuif Cedex, France

Research Site, Budapest, Hungary

Research Site, Debrecen, Hungary

Research Site, Györ, Hungary

Research Site, Szeged, Hungary

Research Site, Lido di Camaiore, Italy

Research Site, Modena, Italy

Research Site, Treviglio, Italy

Research Site, Ciudad de Panama, Panama

Research Site, Lima, Peru

Research Site, Barcelona, Spain

Research Site, Madrid, Spain

Research Site, Valencia, Spain

Research Site, Uppsala, Sweden

Research Site, Chur, Switzerland

Research Site, Glasgow, United Kingdom

Research Site, Leicester, United Kingdom

Research Site, London, United Kingdom

Research Site, Nottingham, United Kingdom

Research Site, Surrey, United Kingdom

Research Site, Halifax, Nova Scotia, Canada

Research Site, London, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Additional Information

Study Report Synopsis

Starting date: June 2009
Last updated: June 12, 2015

Page last updated: August 23, 2015

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