Back to resultsAssessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD2281
matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Serous,, Ovarian cancer,, PARP,, BRCA1,, BRCA2,, Poly(ADP ribose) polymerases,, Platinum sensitive,, Homologous Recombination Deficiency (HRD)
Eligibility Criteria
Inclusion Criteria:
- Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
- Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
- For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
- Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Exclusion Criteria:
- Previous treatment with PARP inhibitors including AZD2281
- Patients with low grade ovarian carcinoma.
- Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
- Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
AZD2281
matching placebo
Outcomes
Primary Outcome Measures
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)]
Secondary Outcome Measures
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.
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
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]
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.
Percentage Change From Baseline in Tumour Size at Week 24
Percentage change from baseline to Week 24 in target tumour size.
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Best percentage change from baseline in CA-125 level
Best Objective Response
Best overall response from radiologic assessments. [FAS]
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]
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]
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]
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]
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]
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]
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]
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]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00753545
Brief Title
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Official Title
Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2008 (Actual)
Primary Completion Date
June 30, 2010 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Serous,, Ovarian cancer,, PARP,, BRCA1,, BRCA2,, Poly(ADP ribose) polymerases,, Platinum sensitive,, Homologous Recombination Deficiency (HRD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD2281
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
AZD2281
Other Intervention Name(s)
Olaparib, Lynparza
Intervention Description
Tablets Oral BID
Intervention Type
Drug
Intervention Name(s)
matching placebo
Intervention Description
matching placebo bid
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
Description
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)]
Time Frame
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 Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Title
Objective Response Rate (ORR) (According to RECIST)
Description
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
Time Frame
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.
Title
Disease Control Rate
Description
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]
Time Frame
Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Title
Duration of Response
Description
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.
Time Frame
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.
Title
Percentage Change From Baseline in Tumour Size at Week 24
Description
Percentage change from baseline to Week 24 in target tumour size.
Time Frame
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.
Title
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Description
Best percentage change from baseline in CA-125 level
Time Frame
CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Title
Best Objective Response
Description
Best overall response from radiologic assessments. [FAS]
Time Frame
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.
Title
RECIST and CA-125 Response Separately and Combined
Description
RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]
Time Frame
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.
Title
Time to Earlier of CA-125 or RECIST Progression
Description
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]
Time Frame
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.
Title
Improvement Rate for FACT-O Symptom Index (FOSI)
Description
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]
Time Frame
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Title
Improvement Rate for Trial Outcome Index (TOI)
Description
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]
Time Frame
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Title
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Description
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]
Time Frame
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Title
FACT-O Symptom Index (FOSI) Time to Worsening
Description
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]
Time Frame
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Title
Trial Outcome Index(TOI)Time to Worsening
Description
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]
Time Frame
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Title
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
Description
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]
Time Frame
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Exclusion Criteria:
Previous treatment with PARP inhibitors including AZD2281
Patients with low grade ovarian carcinoma.
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Sovak, BSc, MBCHB, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof Jonathan A Lederman
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Research Site
City
East Bentleigh
ZIP/Postal Code
3165
Country
Australia
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Research Site
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Research Site
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Wein
ZIP/Postal Code
1130
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Research Site
City
Caen Cedex
ZIP/Postal Code
14076
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30177
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Research Site
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Research Site
City
Grzepnica
ZIP/Postal Code
72-003
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20 - 081
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Research Site
City
Poznań
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Research Site
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Research Site
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
Research Site
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197002
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Research Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Research Site
City
Ternopil
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Research Site
City
Uzhhorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XR
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Research Site
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
35170751
Citation
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.
Results Reference
derived
PubMed Identifier
27824811
Citation
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.
Results Reference
derived
PubMed Identifier
27617661
Citation
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.
Results Reference
derived
PubMed Identifier
27062051
Citation
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.
Results Reference
derived
PubMed Identifier
24882434
Citation
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. Erratum In: Lancet Oncol. 2015 Apr;16(4):e158.
Results Reference
derived
PubMed Identifier
22452356
Citation
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.
Results Reference
derived
PubMed Identifier
19238149
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=242&filename=CSR_Synopsis_D0810C00019.pdf
Description
CSR_Synospsis-D0810C00019.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=242&filename=D0810C00019_redacted_protocol.pdf
Description
D0810C00019_redacted_protocol
Learn more about this trial
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
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