AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer (OVERT-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00610714
First received: January 23, 2008
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: May 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Ovarian Neoplasms
Ovarian Cancer
Interventions: Drug: AZD0530
Drug: Carboplatin
Drug: Paclitaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 58 cancer clinics in 12 countries (Bulgaria, Canada, Denmark, France, Netherlands, Norway, Peru, Portugal, Romania, Russia, Spain and UK) between April 2008 and March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following enrolment there was a 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.

Reporting Groups
  Description
AZD0530 , Paclitaxel , Carboplatin i.v. AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
Carboplatin ,Paclitaxel Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;

Participant Flow:   Overall Study
    AZD0530 , Paclitaxel , Carboplatin i.v.     Carboplatin ,Paclitaxel  
STARTED     105     106  
COMPLETED     79     82  
NOT COMPLETED     26     24  
Adverse Event                 3                 1  
Death                 12                 18  
Withdrawal by Subject                 9                 3  
Study completion at 120 PFS events                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD0530 , Paclitaxel , Carboplatin i.v. AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
Carboplatin ,Paclitaxel Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
Total Total of all reporting groups

Baseline Measures
    AZD0530 , Paclitaxel , Carboplatin i.v.     Carboplatin ,Paclitaxel     Total  
Number of Participants  
[units: participants]
  105     106     211  
Age  
[units: Years]
Mean ± Standard Deviation
  57.4  ± 9.9     59.1  ± 10.2     58.265  ± 10.077  
Gender, Customized  
[units: Participants]
     
Female     105     106     211  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     94     99     193  
Black     1     0     1  
Asian     2     3     5  
Other     8     4     12  
Body Surface Area (BSA)  
[units: m^2]
Mean ± Standard Deviation
  1.758  ± 0.17     1.766  ± 0.206     1.762  ± 0.189  
World Health Organization (WHO) Performance Status [1]
[units: Participants]
     
0     60     63     123  
1     41     42     83  
2     4     1     5  
3     0     0     0  
4     0     0     0  
Primary Tumour Location (Number of Participants)  
[units: Participants]
     
Ovary     98     98     196  
Peritoneum     4     5     9  
Uterine/fallopian tube     3     1     4  
Site cannot be determined     0     1     1  
Unavailable     0     1     1  
Tumour Grade  
[units: Participants]
     
Well Differentiated (G1)     8     8     16  
Mod. Differentiated (G2)     29     25     54  
Unavailable (G3)     45     53     98  
Undifferentiated (G4)     4     6     10  
Unassessable (GX)     15     14     29  
Missing     4     0     4  
[1] minimum value=0=best outcome, maximum value=4=worst outcome



  Outcome Measures
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1.  Primary:   Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)   [ 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) ]

2.  Secondary:   Progression-free Survival (PFS) as Evaluated by RECIST   [ 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) ]

3.  Secondary:   Overall Survival (Number of Deaths)   [ Time Frame: Date of randomization to death due to any cause ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00610714     History of Changes
Other Study ID Numbers: D8180C00015, AZD0530 Study 15
Study First Received: January 23, 2008
Results First Received: May 3, 2011
Last Updated: December 14, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency