Ovarian Cancer Clinical Trial
— OVERT-1Official 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
The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer
| Status | Completed |
| Enrollment | 211 |
| Est. completion date | January 2012 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Denmark | Research Site | Alborg | |
| Denmark | Research Site | Herning | |
| Denmark | Research Site | Naestved | |
| France | Research Site | Avignon | |
| France | Research Site | Bordeaux Cedex | |
| France | Research Site | Caen Cedex | |
| France | Research Site | Lyon Cedex 08 | |
| France | Research Site | Montpellier Cedex 5 | |
| France | Research Site | Nantes | |
| France | Research Site | Paris | Cedex 04 |
| France | Research Site | Pierre Benite Cedex | |
| France | Research Site | Reims Cedex | |
| France | Research Site | Vandoeuvre Les Nancy | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Den Haag | |
| Netherlands | Research Site | Leiden | |
| Netherlands | Research Site | Nijmegen | |
| Norway | Research Site | Bergen | |
| Norway | Research Site | Oslo | |
| Peru | Research Site | Lima | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Funchal | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Porto | |
| Romania | Research Site | Alba Iulia | |
| Romania | Research Site | Baia Mare | Maramures |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Cluj Napoca | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhniy Novgorod | |
| Russian Federation | Research Site | St. Petersburg | |
| Spain | Research Site | Barcelona | Cataluna |
| Spain | Research Site | Cordoba | Andalucia |
| Spain | Research Site | Hospitalet Dellobregat(barcelo | Cataluna |
| Spain | Research Site | Madrid | Comunidad de Madrid |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| United Kingdom | Research Site | Coventry |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Bulgaria, Canada, Denmark, France, Netherlands, Norway, Peru, Portugal, Romania, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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) | No |
| Secondary | 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. | 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) | No |
| Secondary | 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 | Date of randomization to death due to any cause | No |
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