Clinical trial NCT00610714: AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
Official title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Ovarian Cancer
Keywords: Cancer
Tumour
Ovarian Neoplasms
Ovarian Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 211
Sex: FEMALE
Minimum age (years): 18
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 AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of advanced ovarian cancer
* Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
* Estimated life expectancy of more than 12 weeks

Exclusion Criteria:

* Central Nervous System (CNS) metastases
* Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low haemoglobin
* Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception

Primary outcomes:
measure: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
timeFrame: Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)
Secondary outcomes:
measure: Progression-free Survival (PFS) as Evaluated by RECIST
timeFrame: Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)
measure: Overall Survival (Number of Deaths)
timeFrame: Date of randomization to death due to any cause
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Alborg
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Naestved
country: Denmark
facility: Research Site
city: Paris
country: France
facility: Research Site
state: Cedex 04
city: Avignon
country: France
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Caen Cedex
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Funchal
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
state: Maramures
city: Alba Iulia
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucia
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet Dellobregat(barcelo
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Coventry
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
name: Chris Poole, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mireille Cantarini, MD
role: STUDY_DIRECTOR
References:
citation: Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.