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AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

NCT00610714CompletedPHASE2INTERVENTIONAL

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

Key Facts

Lead Sponsor

AstraZeneca

Enrollment

211

Start Date

2008-04-01

Completion Date

2009-08-01

Study Type

INTERVENTIONAL

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

Interventions

AZD0530CarboplatinPaclitaxel

Conditions

Ovarian NeoplasmsOvarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)

Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.

Time frame: 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

Progression-free Survival (PFS) as Evaluated by RECIST

Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.

Time frame: 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)

Overall Survival (Number of Deaths)

Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead

Time frame: Date of randomization to death due to any cause

Locations

Research Site, Pleven, Bulgaria

Research Site, Plovdiv, Bulgaria

Research Site, Sofia, Bulgaria

Research Site, Varna, Bulgaria

Research Site, Edmonton, Canada

Research Site, Vancouver, Canada

Research Site, St. John's, Canada

Research Site, Ottawa, Canada

Research Site, Toronto, Canada

Research Site, Montreal, Canada

Research Site, Québec, Canada

Research Site, Sherbrooke, Canada

Research Site, Aalborg, Denmark

Research Site, Herning, Denmark

Research Site, Næstved, Denmark

Research Site, Paris, France

Research Site, Avignon, France

Research Site, Bordeaux, France

Research Site, Caen, France

Research Site, Lyon, France

Research Site, Montpellier, France

Research Site, Nantes, France

Research Site, Pierre-Bénite, France

Research Site, Reims, France

Research Site, Vandœuvre-lès-Nancy, France

Research Site, Amsterdam, Netherlands

Research Site, Leiden, Netherlands

Research Site, Nijmegen, Netherlands

Research Site, The Hague, Netherlands

Research Site, Bergen, Norway

Research Site, Oslo, Norway

Research Site, Lima, Peru

Research Site, Coimbra, Portugal

Research Site, Funchal, Portugal

Research Site, Lisbon, Portugal

Research Site, Porto, Portugal

Research Site, Baia Mare, Romania

Research Site, Alba Iulia, Romania

Research Site, Bucharest, Romania

Research Site, Cluj-Napoca, Romania

Research Site, Kazan', Russia

Research Site, Moscow, Russia

Research Site, Nizhny Novgorod, Russia

Research Site, Saint Petersburg, Russia

Research Site, Córdoba, Spain

Research Site, Barcelona, Spain

Research Site, Hospitalet Dellobregat(barcelo, Spain

Research Site, Madrid, Spain

Research Site, Valencia, Spain

Research Site, Coventry, United Kingdom

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.