Phase II Study of AZD2281 in Patients With Known BRCA Mut... | NCT00679783 | Trialant
NCT00679783
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jul 12, 2023Actual
Enrollment
99Actual
Phase
Phase 2
Conditions
Ovarian Carcinoma
Breast Cancer
Interventions
AZD2281
Countries
Canada
Protocol Section
Identification Module
NCT ID
NCT00679783
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D0810C00020
Secondary IDs
Not provided
Brief Title
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
Official Title
Phase II, Open Label, Non-Randomized Study of AZD2281 in the Treatment of Patients With Known BRCA or Recurrent High Grade Serous/ Undifferentiated Tubo-Ovarian Carcinoma and in Known BRCA or Triple Negative Breast Cancer to Determine Response Rate and Correlative Markers of Response
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 8, 2008Actual
Primary Completion Date
Mar 26, 2010Actual
Completion Date
Jul 20, 2022Actual
First Submitted Date
May 15, 2008
First Submission Date that Met QC Criteria
May 15, 2008
First Posted Date
May 19, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 19, 2011
Results First Submitted that Met QC Criteria
Jul 19, 2011
Results First Posted Date
Aug 12, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 7, 2023
Last Update Posted Date
Jul 12, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Name
Class
British Columbia Cancer Agency
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study
Detailed Description
Not provided
Conditions Module
Conditions
Ovarian Carcinoma
Breast Cancer
Keywords
Breast cancer
Ovarian cancer
BRCA
Triple negative
Poly(ADP ribose) polymerases
Known BRCA or Recurrent High Grade Serious/ Undifferentiated Tubo- Ovarian Carcinoma
Known BRCA or Triple Negative Breast Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
99Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
AZD2281, PARP inhibitor Olaparib tablets, oral
Drug: AZD2281
2
Experimental
Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally
AZD2281, PARP inhibitor Olaparib tablets, oral
Drug: AZD2281
3
Experimental
High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.
Secondary Outcomes
Measure
Description
Time Frame
Disease Control Rate (DCR)
Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)
16 Weeks
Duration of Response
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
Performance status of no more than 2.
Exclusion Criteria:
Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .
Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
The study enrolled both known BRCA mutation carriers and patients with unknown BRCA status. Those with unknown status at entry had to provide a DNA sample for BRCA. One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis. Study data are summarised by confirmed mutation status.
Recruitment Details
The first patient was enrolled on July 8, 2008 and efficacy and safety data were collected up to the data cut-off of March 26, 2010. Patients were enrolled at 6 centres in Canada. Of the 112 patients who gave informed consent 21 patients failed eligibility criteria or withdrew their consent and were not allocated to treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
FG001
BRCA Positive Serous Ovarian
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
4 parallel arms for the 2 tumour types and the BRCA mutation groups:
Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally
High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.
RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
Best Percentage Change From Baseline in Tumour Size
The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.
CA-125 Levels (Ovarian Cancer Patients Only)
A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.
24 weeks
Progression Free Survival (PFS)
PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.
RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
Vancouver
British Columbia
V5Z 4E6
Canada
Research Site
Halifax
Nova Scotia
B3H 1V7
Canada
Research Site
Hamilton
Ontario
L8V 5C2
Canada
Research Site
Toronto
Ontario
M4N 3M5
Canada
Research Site
Montreal
Quebec
H2X 3E4
Canada
Derived
Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6.
Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, Huntsman D, Clemons M, Gilks B, Yerushalmi R, Macpherson E, Carmichael J, Oza A. Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. Lancet Oncol. 2011 Sep;12(9):852-61. doi: 10.1016/S1470-2045(11)70214-5. Epub 2011 Aug 19.
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
FG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
FG003
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
FG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
FG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
FG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
FG0004 subjectsGave Informed consent and passed screening
FG00113 subjectsGave Informed consent and passed screening
FG0023 subjectsGave Informed consent and passed screening
FG00345 subjectsGave Informed consent and passed screening
FG0045 subjectsGave Informed consent and passed screening
FG0055 subjectsGave Informed consent and passed screening
FG00616 subjectsGave Informed consent and passed screening
COMPLETED
FG0002 subjectsPatients who discontinued treatment following disease progression.
FG00110 subjectsPatients who discontinued treatment following disease progression.
FG0022 subjectsPatients who discontinued treatment following disease progression.
FG00325 subjectsPatients who discontinued treatment following disease progression.
FG0044 subjectsPatients who discontinued treatment following disease progression.
FG0055 subjectsPatients who discontinued treatment following disease progression.
FG00615 subjectsPatients who discontinued treatment following disease progression.
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG00320 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Not Captured
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
Ongoing at data cut-off
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0039 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BG003
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
BG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00113
BG0023
BG00344
BG0045
BG0055
BG00616
BG00790
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Year
Title
Denominators
Categories
Title
Measurements
BG00060± 18.7
BG00153.7± 7.3
BG00260.3± 12.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG00113
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
Posted
Number
95% Confidence Interval
Percentage of participants
Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.
ID
Title
Description
OG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
OG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
OG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG003
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
OG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
OG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Units
Counts
Participants
OG0004
OG00113
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00075(30.06 to 95.44)
OG00130.77(12.68 to 57.63)
OG0020(0 to 56.15)
OG003
Secondary
Disease Control Rate (DCR)
Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)
Posted
Number
95% Confidence Interval
Percentage of participants
16 Weeks
ID
Title
Description
OG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
OG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
OG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG003
BRCA Negative Serous Ovarian
Secondary
Duration of Response
Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.
Posted
Median
Full Range
Days
RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
ID
Title
Description
OG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
OG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
OG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG003
Secondary
Best Percentage Change From Baseline in Tumour Size
The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
Posted
Median
Full Range
Percentage
Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.
ID
Title
Description
OG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
OG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
OG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
Secondary
CA-125 Levels (Ovarian Cancer Patients Only)
A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.
Posted
Number
95% Confidence Interval
Percentage of participants
24 weeks
ID
Title
Description
OG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
OG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
OG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG003
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
Secondary
Progression Free Survival (PFS)
PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.
Posted
Median
Full Range
Days
RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
ID
Title
Description
OG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
OG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
OG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG003
BRCA Negative Serous Ovarian
Time Frame
Not provided
Description
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
0
4
4
4
EG001
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
4
13
13
13
EG002
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
0
3
3
3
EG003
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
6
44
44
44
EG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
0
5
5
5
EG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
2
5
5
5
EG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
2
16
15
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG0030 affected44 at risk
EG0040 affected5 at risk
EG0051 affected5 at risk
EG0060 affected16 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Left Ventricular Dysfunction
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Pleural Infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Haemoglobin Decreased
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Chronic Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hernia Repair
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG0032 affected44 at risk
EG0041 affected5 at risk
EG0051 affected5 at risk
EG0062 affected16 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Visual Impairment
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0003 affected4 at risk
EG0019 affected13 at risk
EG0022 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0014 affected13 at risk
EG0021 affected3 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected13 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0015 affected13 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected13 at risk
EG0020 affected3 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Gingival Pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Anal Haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia Oral
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Mouth Haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Oesophageal Pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Oral Discomfort
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 13.1
Systematic Assessment
EG0004 affected4 at risk
EG00112 affected13 at risk
EG0021 affected3 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected13 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected13 at risk
EG0021 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Axillary Pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Face Oedema
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Feeling Hot
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Injection Site Reaction
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Localised Oedema
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0021 affected3 at risk
EG003
Secretion Discharge
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Thirst
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hepatic Haemorrhage
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Breast Cellulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Oral Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0021 affected3 at risk
EG003
Skin Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Vaginal Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Viral Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Vulvovaginitis Streptococcal
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Tooth Injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Weight Decreased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Alanine Aminotransferase Increased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Aspartate Aminotransferase Increased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Blood Alkaline Phosphatase Increased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Blood Glucose Increased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Blood Iron Decreased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Cardiac Murmur
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram Qt Prolonged
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Gamma-Glutamyltransferase Increased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Haemoglobin Decreased
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0017 affected13 at risk
EG0021 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0021 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected13 at risk
EG0020 affected3 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0015 affected13 at risk
EG0021 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0003 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0016 affected13 at risk
EG0021 affected3 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0021 affected3 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Memory Impairment
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Mental Impairment
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Psychomotor Hyperactivity
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Sinus Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Mood Altered
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0021 affected3 at risk
EG003
Breast Pain
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Genital Rash
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Oedema Genital
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Pelvic Discomfort
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0015 affected13 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected13 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Upper Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected13 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Pain Of Skin
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Skin Hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Skin Nodule
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected13 at risk
EG0020 affected3 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0021 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected13 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Gerard Lynch
AstraZeneca
aztrial_results_posting@astrazeneca.com
ID
Term
D010051
Ovarian Neoplasms
D001943
Breast Neoplasms
D064726
Triple Negative Breast Neoplasms
Ancestor Terms
ID
Term
D004701
Endocrine Gland Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C531550
olaparib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
61
± 9.5
BG00449.4± 20.5
BG00544.8± 15.5
BG00648.8± 5.5
BG00752.9± 13
3
BG00344
BG0045
BG0055
BG00616
BG00790
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
43
OG0044
OG0054
OG00615
25.58
(14.93 to 40.24)
OG0040(0 to 48.99)
OG0050(0 to 48.99)
OG0060(0 to 20.39)
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
OG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
OG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Units
Counts
Participants
OG0004
OG00113
OG0023
OG00344
OG0045
OG0055
OG00616
Title
Denominators
Categories
Title
Measurements
OG00075(30.06 to 95.44)
OG00153.85(29.14 to 76.79)
OG0020(0 to 56.15)
OG00347.73(33.75 to 62.06)
OG00460(23.07 to 88.24)
OG00520(3.62 to 62.45)
OG0060(0 to 19.36)
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
OG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
OG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Units
Counts
Participants
OG0003
OG0014
OG0020
OG00311
OG0040
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG000277(261 to 504)
OG001113(109 to 446)
OG003384(105 to 396)
OG003
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
OG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
OG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Units
Counts
Participants
OG0004
OG00113
OG0022
OG00338
OG0044
OG0054
OG00614
Title
Denominators
Categories
Title
Measurements
OG000-44.5(-64 to 4)
OG001-21.6(-100 to 16)
OG00233.6(14 to 53)
OG003-14.1(-95 to 83)
OG004-35.3(-48 to 10)
OG005-36.4(-50 to 11)
OG00621.3(-3 to 50)
OG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
OG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
OG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Units
Counts
Participants
OG0004
OG00112
OG0023
OG00335
OG0040
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG00075(30.06 to 95.44)
OG00133.33(13.81 to 60.94)
OG0020(0 to 56.15)
OG00328.57(16.33 to 45.05)
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
OG004
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
OG005
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
OG006
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.