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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003439-18 | EudraCT Number |
Not provided
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The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD2281 |
|
| 2 | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2281 | Drug | Tablets Oral BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) | PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)] | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive. | Follow up every 12 weeks post progression, assessed maximum up to 90 months. |
| Objective Response Rate (ORR) (According to RECIST) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Mika Sovak, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Prof Jonathan A Lederman | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berkeley | California | 94704 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39695768 | Derived | Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5. | |
| 35170751 |
| Label | URL |
|---|---|
| CSR\_Synopsis\_Redacted | View source |
Not provided
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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at 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.
It was planned that 250 women with advanced platinum sensitive serous ovarian cancer who had received 2 or more previous platinum-containing regimens and demonstrated an objective stable maintained response in the last platinum regimen prior to enrolment were to receive olaparib 400 mg bd or matching placebo in a 1:1 ratio. 265 randomised.
The first patient was enrolled on 28 August 2008 and the last patient was enrolled on 9 February 2010. Patients were enrolled at 82 centres in 16 countries. Of the 326 patients enrolled, 265 were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib 400 mg bd | AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily |
| FG001 | Placebo bd | olaparib matching placebo oral capsules twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| matching placebo |
| Drug |
matching placebo bid |
|
For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set |
| Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
| Disease Control Rate | Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS] | Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week). |
| Duration of Response | Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn. | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
| Percentage Change From Baseline in Tumour Size at Week 24 | Percentage change from baseline to Week 24 in target tumour size. | Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
| Best Percentage Change in Cancer Antigen 125 (CA-125) Levels | Best percentage change from baseline in CA-125 level | CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months. |
| Best Objective Response | Best overall response from radiologic assessments. [FAS] | Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months. |
| RECIST and CA-125 Response Separately and Combined | RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response] | Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months. |
| Time to Earlier of CA-125 or RECIST Progression | Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS] | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months. |
| Improvement Rate for FACT-O Symptom Index (FOSI) | The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set] | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
| Improvement Rate for Trial Outcome Index (TOI) | The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set] | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
| Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) | The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set] | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
| FACT-O Symptom Index (FOSI) Time to Worsening | The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set] | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
| Trial Outcome Index(TOI)Time to Worsening | The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set] | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
| Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening | The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set] | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
| San Francisco |
| California |
| 94115 |
| United States |
| Research Site | West Hollywood | California | 90048 | United States |
| Research Site | Sunrise | Florida | 33027 | United States |
| Research Site | West Palm Beach | Florida | 33401 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Providence | Rhode Island | 02905 | United States |
| Research Site | Adelaide | 5000 | Australia |
| Research Site | East Bentleigh | 3165 | Australia |
| Research Site | Heidelberg | 3084 | Australia |
| Research Site | Melbourne | 3000 | Australia |
| Research Site | Nambour | 4560 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | South Brisbane | 4101 | Australia |
| Research Site | Toorak Gardens | 5065 | Australia |
| Research Site | Innsbruck | 6020 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Wein | 1130 | Austria |
| Research Site | Brussels | 1090 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Québec | Quebec | G1R 2J6 | Canada |
| Research Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Tallinn | 11619 | Estonia |
| Research Site | Tartu | 51014 | Estonia |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Caen | 14076 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Nantes | 44202 | France |
| Research Site | Paris | 75004 | France |
| Research Site | Paris | 75020 | France |
| Research Site | Reims | 51056 | France |
| Research Site | Bonn | 53105 | Germany |
| Research Site | Düsseldorf | 40217 | Germany |
| Research Site | Essen | 45147 | Germany |
| Research Site | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Göttingen | 37075 | Germany |
| Research Site | Hanover | 30177 | Germany |
| Research Site | Kiel | 24105 | Germany |
| Research Site | Marburg | 35043 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | Rostock | 18059 | Germany |
| Research Site | Ulm | 89081 | Germany |
| Research Site | Wiesbaden | 65199 | Germany |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Holon | 58100 | Israel |
| Research Site | Jerusalem | 91031 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Nahariya | 22100 | Israel |
| Research Site | Ramat Gan | 52621 | Israel |
| Research Site | Tel Aviv | 64239 | Israel |
| Research Site | Ẕerifin | 70300 | Israel |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Amsterdam | 1081 HV | Netherlands |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Grzepnica | 72-003 | Poland |
| Research Site | Lublin | 20 - 081 | Poland |
| Research Site | Poznan | 60-569 | Poland |
| Research Site | Poznan | 61-866 | Poland |
| Research Site | Poznan | Poland |
| Research Site | Szczecin | 70-111 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Baia Mare | 430222 | Romania |
| Research Site | Cluj-Napoca | 400015 | Romania |
| Research Site | Iași | 700106 | Romania |
| Research Site | Suceava | 720237 | Romania |
| Research Site | Barnaul | 656049 | Russia |
| Research Site | Obninsk | 249036 | Russia |
| Research Site | Orenburg | 460021 | Russia |
| Research Site | Perm | 614066 | Russia |
| Research Site | Pyatigorsk | 357502 | Russia |
| Research Site | Saint Petersburg | 197002 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Voronezh | 394000 | Russia |
| Research Site | Yekaterinburg | 620036 | Russia |
| Research Site | Córdoba | 14004 | Spain |
| Research Site | Madrid | 08035 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Valencia | 46010 | Spain |
| Research Site | Donetsk | 83092 | Ukraine |
| Research Site | Kharkiv Region | 61024 | Ukraine |
| Research Site | Kyiv | 03022 | Ukraine |
| Research Site | Kyiv | 03115 | Ukraine |
| Research Site | Lutsk | 43018 | Ukraine |
| Research Site | Odesa | 65009 | Ukraine |
| Research Site | Odesa | 65055 | Ukraine |
| Research Site | Ternopil | 46023 | Ukraine |
| Research Site | Uzhhorod | 88014 | Ukraine |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | Edinburgh | EH4 2XR | United Kingdom |
| Research Site | London | NW1 2PG | United Kingdom |
| Research Site | London | SW17 0QT | United Kingdom |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Research Site | Sutton | SM2 5PT | United Kingdom |
| 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. |
| 27824811 | Derived | Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8. |
| 27617661 | Derived | Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9. |
| 27062051 | Derived | Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8. |
| 24882434 | Derived | Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31. |
| 22452356 | Derived | Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib 400 mg bd | AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily |
| BG001 | Placebo bd | olaparib matching placebo oral capsules twice daily |
| BG002 | 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 |
| ||||||||||||||||
| Time to progression | The time to disease progression from the completion of the penultimate platinum containing therapy (last dose) prior to enrolment on the study. | Number | participants |
| |||||||||||||||
| Objective response | Objective response to the last platinum containing regimen prior to enrolment on the study:
| 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) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) | PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)] | Posted | Median | 95% Confidence Interval | Months | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
|
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| Secondary | Overall Survival (OS) | OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive. | Posted | Median | 95% Confidence Interval | Months | Follow up every 12 weeks post progression, assessed maximum up to 90 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) (According to RECIST) | For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set | Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline | Posted | Number | percentage of participants | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate | Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS] | Posted | Number | percentage of participants | Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week). |
|
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| Secondary | Duration of Response | Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn. | Posted | Median | 95% Confidence Interval | Months | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
|
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| Secondary | Percentage Change From Baseline in Tumour Size at Week 24 | Percentage change from baseline to Week 24 in target tumour size. | Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline. | Posted | Least Squares Mean | Full Range | Percent change in tumour size | Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Percentage Change in Cancer Antigen 125 (CA-125) Levels | Best percentage change from baseline in CA-125 level | A subset of the FAS with baseline and at least 1 follow-up value of CA-125 | Posted | Median | Full Range | percentage of change | CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Objective Response | Best overall response from radiologic assessments. [FAS] | Posted | Number | Participants | Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | RECIST and CA-125 Response Separately and Combined | RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response] | Posted | Number | Participants | Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Earlier of CA-125 or RECIST Progression | Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS] | Posted | Median | 95% Confidence Interval | Months | Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement Rate for FACT-O Symptom Index (FOSI) | The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set] | Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline | Posted | Number | percentage of evaluable participants | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement Rate for Trial Outcome Index (TOI) | The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set] | Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline | Posted | Number | percentage of evaluable participants | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) | The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set] | Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline | Posted | Number | percentage of evaluable participants | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FACT-O Symptom Index (FOSI) Time to Worsening | The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set] | Posted | Median | 95% Confidence Interval | Months | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trial Outcome Index(TOI)Time to Worsening | The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set] | Posted | Median | 95% Confidence Interval | Months | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening | The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set] | Posted | Median | 95% Confidence Interval | Months | Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. |
|
|
Not provided
128 participants in Placebo as 1 participant withdrew consent prior to 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 400 mg bd | 31 | 136 | 129 | 136 | |||
| EG001 | Placebo | 11 | 128 | 111 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL INCARCERATED HERNIA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| INTRA-ABDOMINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| HERNIA PAIN | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| IODINE ALLERGY | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| ENDOPHTHALMITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| LIVER ABSCESS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| INTRADUCTAL PROLIFERATIVE BREAST LESION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| HAEMORRHAGIC STROKE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ESSENTIAL HYPERTENSION | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
For OM DoR: The subset of patients evaluable for response who responded to study treatment.Values in results table may be under-estimates as some patients had not progressed at final analysis,so true duration is likely to be greater than in database.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@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 |
Not provided
Not provided
Not provided
| Male |
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| >12 months |
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| Partial response |
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