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Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (OPINION)

Primary Purpose

Non-Germline BRCA Mutated Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olaparib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Germline BRCA Mutated Ovarian Cancer focused on measuring Ovarian cancer, non-gBRCA, Platinum, Chemotherapy

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Female patients with histologically diagnosed relapsed HGSOC (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid ovarian cancer
  • Documented gBRCA1/2 mutation status
  • Patients must have completed at least 2 previous courses of platinum containing therapy
  • Patients must have normal organ and bone marrow function measured within 28 days of starting study treatment
  • ECOG performance status 0-1 (see Appendix E)
  • Patients must have a life expectancy ≥16 weeks
  • Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment OR No evidence of disease following a complete response to chemotherapy
  • An appropriately prepared tumour sample from the cancer, of sufficient quantity and quality (as specified in the Central Laboratory Services Manual) must be available for future central testing of tumour genetic status

Exclusion Criteria:

  • Patients receiving any systemic hormonal therapy, chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to start of study treatment
  • Any previous treatment with PARP inhibitor, including olaparib
  • Patients with a germline BRCA mutation that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental / lead to loss of function)
  • Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
  • Concomitant use of known strong CYP3A inhibitors and strong (or moderate CYP3A inducers
  • Persistent toxicities (≥ Grade 2 Common Terminology Criteria for Adverse Event (CTCAE) adverse event) caused by previous cancer therapy, excluding alopecia
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML
  • Patients with symptomatic uncontrolled brain metastases

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olaparib

Arm Description

Olaparib will be supplied as film-coated tablets containing 150 mg or 100 mg of olaparib. Patients will be administered olaparib orally twice daily (bid) at 300 mg.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
PFS is defined as the time from date of first dose until the date of objective radiological disease progression. Assessed according to modified Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression). Progression was determined by investigator assessment, RECIST 1.1. Calculated using the Kaplan-Meier technique. Confidence intervals (CI) for median PFS was derived based on Brookmeyer-Crowley method.

Secondary Outcome Measures

Time to First Subsequent Therapy or Death (TFST)
TFST is defined as the time from date of first dose to date of first subsequent treatment commencement or death due to any cause if this occurs before commencement of first subsequent treatment. Calculated using the Kaplan-Meier technique. CI for median TFST was derived based on Brookmeyer-Crowley method.
Time to Treatment Discontinuation or Death (TDT)
TDT is defined as the time from date of first dose to date of study drug discontinuation or death due to any cause if this occurs before study drug discontinuation. Calculated using the Kaplan-Meier technique. CI for median TDT was derived based on Brookmeyer-Crowley method.
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status
HRD/BRCAm status was based on the central blood and tumour assessments. Assessed according to modified RECIST 1.1 or death (by any cause in the absence of progression). Progression was determined by investigator assessment, RECIST 1.1. Calculated using the Kaplan-Meier technique. CI for median PFS was derived based on Brookmeyer-Crowley method.
Chemotherapy-free Interval (CT-FI)
CT-FI is defined as the time from the date of the last dose of platinum chemotherapy prior to olaparib maintenance therapy until the date of initiation of the next anticancer therapy. Calculated using the Kaplan-Meier technique. CI for median CT-FI was derived based on Brookmeyer-Crowley method.
Overall Survival (OS)
OS is defined as the time from the date of first dose of olaparib to the date of death from any cause. Calculated using the Kaplan-Meier technique. CI for median OS was derived based on Brookmeyer-Crowley method.
Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period
Improvement was defined as a functional assessment of cancer therapy - ovarian (FACT-O) TOI response of "any improvement" at any time point over the course of treatment. The TOI is an established single targeted index composed of the following scales of the FACT-O: physical and functional well-being and additional concerns. The range of possible scores for the FACT-O TOI is 0-100, with a higher score indicating better health related quality of life (HRQoL). An increase in score from baseline indicates an improvement in HRQoL.
Percentage of Patients With a 10-Point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period
10-point deterioration was defined as a FACT-O TOI response of "10-point deterioration" at any time point over the course of treatment. The TOI is an established single targeted index composed of the following scales of the FACT-O: physical and functional well-being and additional concerns. The range of possible scores for the FACT-O TOI is 0-100, with a higher score indicating better HRQoL. A decrease in score of at least 10 points from baseline was defined as a clinically meaningful deterioration.

Full Information

First Posted
January 3, 2018
Last Updated
October 5, 2022
Sponsor
AstraZeneca
Collaborators
Iqvia Pty Ltd, Myriad Genetics, Inc., Covance, Theradex, Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT03402841
Brief Title
Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients
Acronym
OPINION
Official Title
A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non-Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Iqvia Pty Ltd, Myriad Genetics, Inc., Covance, Theradex, Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy
Detailed Description
Maintenance monotherapy with the potent polyadenosine 5'diphosphoribose [Poly (ADP-ribose)] polymerisation (PARP) inhibitor (PARPi) olaparib will significantly prolong progression-free survival (PFS) in platinum sensitive relapsed non-germline breast cancer susceptibility gene (BRCA) mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. Olaparib is a potent PARPi (PARP-1, -2 and -3) that is being developed as an oral therapy, both as a monotherapy (including maintenance) and for combination with chemotherapy and other anticancer agents. PARP inhibition is a novel approach to targeting tumours with deficiencies in DNA repair mechanisms. PARP enzymes are essential for repairing DNA single strand breaks (SSBs). Inhibiting PARP enzymes leads to the persistence of SSBs, which are then converted to the more serious DNA double strand breaks (DSBs) during the process of DNA replication. During the process of cell division, DSBs can be efficiently repaired in normal cells by homologous recombination (HR) repair. Tumours with HR deficiencies (HRDs), such as ovarian cancers in patients with BRCA1/2 mutations, cannot accurately repair the DNA damage, which may become lethal to cells as it accumulates. In such tumour types, olaparib may offer a potentially efficacious and less toxic cancer treatment compared with currently available chemotherapy regimens. While multiple randomized controlled trials (RCTs) have demonstrated that platinum sensitive BRCAm patients have profound response to maintenance treatment with PARP inhibitors, PARP inhibitors target cells with homologous recombination deficiency (HRD), of which BRCA mutation is only one type. Consistent with the mechanism of action of PARP inhibition, response has also been seen in multiple RCTs in patients who are platinum sensitive but whose tumours do not harbor BRCA mutations. Presumably these responders have defects in other components of HRR pathways, though currently available diagnostic technology is not adequate to reliably identify the full spectrum of HRR deficiencies. Instead, these data support the hypothesis that platinum sensitivity itself is a clinical selection factor for HRD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Germline BRCA Mutated Ovarian Cancer
Keywords
Ovarian cancer, non-gBRCA, Platinum, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Single arm study
Masking
None (Open Label)
Masking Description
Open
Allocation
Non-Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olaparib
Arm Type
Experimental
Arm Description
Olaparib will be supplied as film-coated tablets containing 150 mg or 100 mg of olaparib. Patients will be administered olaparib orally twice daily (bid) at 300 mg.
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
Lynparza
Intervention Description
300 mg twice daily - oral
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from date of first dose until the date of objective radiological disease progression. Assessed according to modified Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression). Progression was determined by investigator assessment, RECIST 1.1. Calculated using the Kaplan-Meier technique. Confidence intervals (CI) for median PFS was derived based on Brookmeyer-Crowley method.
Time Frame
Up to maximum of 32 months
Secondary Outcome Measure Information:
Title
Time to First Subsequent Therapy or Death (TFST)
Description
TFST is defined as the time from date of first dose to date of first subsequent treatment commencement or death due to any cause if this occurs before commencement of first subsequent treatment. Calculated using the Kaplan-Meier technique. CI for median TFST was derived based on Brookmeyer-Crowley method.
Time Frame
Up to a maximum of 43 months
Title
Time to Treatment Discontinuation or Death (TDT)
Description
TDT is defined as the time from date of first dose to date of study drug discontinuation or death due to any cause if this occurs before study drug discontinuation. Calculated using the Kaplan-Meier technique. CI for median TDT was derived based on Brookmeyer-Crowley method.
Time Frame
Up to a maximum of 43 months
Title
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status
Description
HRD/BRCAm status was based on the central blood and tumour assessments. Assessed according to modified RECIST 1.1 or death (by any cause in the absence of progression). Progression was determined by investigator assessment, RECIST 1.1. Calculated using the Kaplan-Meier technique. CI for median PFS was derived based on Brookmeyer-Crowley method.
Time Frame
Up to maximum of 32 months
Title
Chemotherapy-free Interval (CT-FI)
Description
CT-FI is defined as the time from the date of the last dose of platinum chemotherapy prior to olaparib maintenance therapy until the date of initiation of the next anticancer therapy. Calculated using the Kaplan-Meier technique. CI for median CT-FI was derived based on Brookmeyer-Crowley method.
Time Frame
Up to a maximum of 43 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of first dose of olaparib to the date of death from any cause. Calculated using the Kaplan-Meier technique. CI for median OS was derived based on Brookmeyer-Crowley method.
Time Frame
Up to a maximum of 43 months
Title
Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period
Description
Improvement was defined as a functional assessment of cancer therapy - ovarian (FACT-O) TOI response of "any improvement" at any time point over the course of treatment. The TOI is an established single targeted index composed of the following scales of the FACT-O: physical and functional well-being and additional concerns. The range of possible scores for the FACT-O TOI is 0-100, with a higher score indicating better health related quality of life (HRQoL). An increase in score from baseline indicates an improvement in HRQoL.
Time Frame
Baseline up to a maximum of 32 months
Title
Percentage of Patients With a 10-Point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period
Description
10-point deterioration was defined as a FACT-O TOI response of "10-point deterioration" at any time point over the course of treatment. The TOI is an established single targeted index composed of the following scales of the FACT-O: physical and functional well-being and additional concerns. The range of possible scores for the FACT-O TOI is 0-100, with a higher score indicating better HRQoL. A decrease in score of at least 10 points from baseline was defined as a clinically meaningful deterioration.
Time Frame
Baseline up to a maximum of 32 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Female patients with histologically diagnosed relapsed HGSOC (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid ovarian cancer Documented gBRCA1/2 mutation status Patients must have completed at least 2 previous courses of platinum containing therapy Patients must have normal organ and bone marrow function measured within 28 days of starting study treatment ECOG performance status 0-1 (see Appendix E) Patients must have a life expectancy ≥16 weeks Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment OR No evidence of disease following a complete response to chemotherapy An appropriately prepared tumour sample from the cancer, of sufficient quantity and quality (as specified in the Central Laboratory Services Manual) must be available for future central testing of tumour genetic status Exclusion Criteria: Patients receiving any systemic hormonal therapy, chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to start of study treatment Any previous treatment with PARP inhibitor, including olaparib Patients with a germline BRCA mutation that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental / lead to loss of function) Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Concomitant use of known strong CYP3A inhibitors and strong (or moderate CYP3A inducers Persistent toxicities (≥ Grade 2 Common Terminology Criteria for Adverse Event (CTCAE) adverse event) caused by previous cancer therapy, excluding alopecia Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML Patients with symptomatic uncontrolled brain metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Wilks
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
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
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Facility Name
Research Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Research Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Research Site
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Research Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Research Site
City
Beer Sheva
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
91096
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Research Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Research Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Research Site
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
424
Country
Norway
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-513
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1400-048
Country
Portugal
Facility Name
Research Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Research Site
City
Hospitalet deLlobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Research Site
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Research Site
City
Frauenfeld
ZIP/Postal Code
8501
Country
Switzerland
Facility Name
Research Site
City
Genève 14
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Research Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Research Site
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Research Site
City
Scarborough
ZIP/Postal Code
YO12 6QL
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 deidentified 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
19553641
Citation
Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009 Jul 9;361(2):123-34. doi: 10.1056/NEJMoa0900212. Epub 2009 Jun 24.
Results Reference
background
PubMed Identifier
18971340
Citation
Rottenberg S, Jaspers JE, Kersbergen A, van der Burg E, Nygren AO, Zander SA, Derksen PW, de Bruin M, Zevenhoven J, Lau A, Boulter R, Cranston A, O'Connor MJ, Martin NM, Borst P, Jonkers J. High sensitivity of BRCA1-deficient mammary tumors to the PARP inhibitor AZD2281 alone and in combination with platinum drugs. Proc Natl Acad Sci U S A. 2008 Nov 4;105(44):17079-84. doi: 10.1073/pnas.0806092105. Epub 2008 Oct 29.
Results Reference
background
PubMed Identifier
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Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

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