|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| 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
| 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. |
| 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. |
| 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; |
| 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
| 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; |
| 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
| 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 ] |
More Information
| 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:
|
| 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 |
|---|
| No text entered. |
| 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: | February 3, 2012 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - French Health Products Safety Agency Russia: Ministry of Health and Social Development 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 |
