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The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD2281 Oral 200 mg BID |
|
| 2 | Active Comparator | Liposomal Doxorubicin |
|
| 3 | Experimental | AZD2281 Oral 400 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2281 | Drug | 400mg Oral twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression) | Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later. | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90048 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407274 | Derived | Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. | |
| 35170751 | Derived | Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4. |
| Label | URL |
|---|---|
| CSR\_Synopsis\_D0810C00012.pdf | View source |
Not provided
97 of 125 screened women with advanced BRCA 1/2 ovarian cancer who had chemotherapy were randomized
First patient enrolled on 30 July 2008 and last patient on 3 March 2009 at 25 centres in 9 countries
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib 200 mg bd | Olaparib (AZD2281) 200 mg oral capsules twice daily |
| FG001 | Olaparib 400 mg bd | Olaparib (AZD2281) 400 mg oral capsules twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomised Part |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Liposomal Doxorubicin |
| Drug |
50mg/m2 Monthly Intravenous |
|
|
| AZD2281 | Drug | 200mg oral twice daily |
|
| Disease Control Rate | The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Overall Duration of Response | The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.) | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Best Percentage Change in Tumour Size | The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Best Percentage Change From Baseline in CA-125 Levels | Best percentage change in cancer antigen 125 (CA-125) levels | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Confirmed RECIST Response and/or CA-125 Response | The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125. | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Overall Survival (OS) | OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals | At the time of the cut-off for the final analysis of overall survival (30 April 2010) |
| Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) | Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100. | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) | Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9. | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| Best QoL Response for FACT-O Symptom Index (FOSI) | Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3. | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| San Francisco |
| California |
| 94115 |
| United States |
| Research Site | Boca Raton | Florida | 33428 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | East Melbourne | 3002 | Australia |
| Research Site | Melbourne, Parkville | VIC 3050 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Cologne | 50937 | Germany |
| Research Site | München | 81377 | Germany |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Ramat Gan | 52621 | Israel |
| Research Site | Tel Aviv | 6423906 | Israel |
| Research Site | Szczecin | 70-111 | Poland |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Hospitalet deLlobregat | 08907 | Spain |
| Research Site | Lund | 22185 | Sweden |
| Research Site | Cambridge | CB2 0QQ | United Kingdom |
| Research Site | Edinburgh | EH4 2XR | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Sutton | SM2 5PT | United Kingdom |
| 32073956 | Derived | Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19. |
| 26961146 | Derived | 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. |
| 23922302 | 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. |
| 19238149 | Derived | Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583. |
| FG002 | Liposomal Doxorubicin | Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Ongoing Initial Study Treatment at DCO |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib 200 mg bd | Olaparib (AZD2281) 200 mg oral capsules twice daily |
| BG001 | Olaparib 400 mg bd | Olaparib (AZD2281) 400 mg oral capsules twice daily |
| BG002 | Liposomal Doxorubicin | Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race/Ethnicity (Jewish ethnicity) | Number | Participants |
| |||||||||||||||
| BRCA status | Number | Participants |
|
| 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 | Progression Free Survival (PFS) | PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression) | Posted | Count of Participants | Participants | Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later. | Posted | Count of Participants | Participants | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate | The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients | Posted | Count of Participants | Participants | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Duration of Response | The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.) | Duration of response is analysed for patients experiencing a response. | Posted | Median | 95% Confidence Interval | Months | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Percentage Change in Tumour Size | The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication | Posted | Median | Full Range | Percent change | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Percentage Change From Baseline in CA-125 Levels | Best percentage change in cancer antigen 125 (CA-125) levels | Posted | Median | Full Range | Percent change | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirmed RECIST Response and/or CA-125 Response | The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125. | Posted | Number | Percentage of participants | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals | Posted | Count of Participants | Participants | At the time of the cut-off for the final analysis of overall survival (30 April 2010) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) | Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100. | Evaluable for TOI at baseline | Posted | Count of Participants | Participants | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) | Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9. | Evaluable for FACT-O at baseline | Posted | Count of Participants | Participants | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best QoL Response for FACT-O Symptom Index (FOSI) | Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3. | Evaluable for FOSI at baseline | Posted | Count of Participants | Participants | At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) | PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression) | Posted | Median | 95% Confidence Interval | Months | Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009) |
|
|
Not provided
AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olaparib 200 mg bd | Olaparib (AZD2281) 200 mg oral capsules twice daily | 5 | 32 | 32 | 32 | ||
| EG001 | Olaparib 400 mg bd | Olaparib (AZD2281) 400 mg oral capsules twice daily | 6 | 32 | 32 | 32 | ||
| EG002 | Liposomal Doxorubicin | Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks | 5 | 32 | 31 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Salivary Hypersecretion | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Intertrigo Candida | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Body Temperature Increased | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight Decreased | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Exfoliative Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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The AEs reported include all events up to the OS data cut-off. After the PFS data cut-off, AEs were only collected for the olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at the time of PFS.
No publication of the study results may be made until publication of the results of the multi-centre study or 2 years after study completion, whichever is the sooner
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula del Rosario | AstraZeneca | +44 7884 735492 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| C563980 | Fanconi Anemia, Complementation Group D1 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C531550 | olaparib |
| C506643 | liposomal doxorubicin |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
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| Other reason |
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| Other |
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| Male |
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| Ashkenazi Jewish |
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| Sephardic Jewish |
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| Not applicable |
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| Other |
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| Deleterious BRCA2 mutation |
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| Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib. | Regression, Cox | Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0). | 0.7794 | An observed p-value of <0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison. | Hazard Ratio (HR) | 0.91 | 95 | 0.48 | 1.74 | Superiority or Other (legacy) |
| Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib. | Regression, Cox | Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0). | 0.6604 | An observed p-value of <0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison. | Hazard Ratio (HR) | 0.86 | 2-Sided | 95 | 0.45 | 1.62 | Superiority or Other (legacy) |
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