Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy
1 other identifier
interventional
272
2 countries
47
Brief Summary
This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Subjects should have received at least 1 prior line of platinum-based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
Typical duration for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2016
CompletedFirst Posted
Study publicly available on registry
December 6, 2016
CompletedStudy Start
First participant enrolled
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2020
CompletedResults Posted
Study results publicly available
April 13, 2022
CompletedApril 13, 2022
March 1, 2022
4 years
November 4, 2016
December 3, 2021
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)
From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)
Secondary Outcomes (7)
Duration of Response, for Those Subjects With a Confirmed Response of CR or PR
From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)
CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response
From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)
Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event
From first dose up until progression, or last evaluable assessment in the absence of progression
Progression Free Survival
From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)
Time to Any Progression
From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)
- +2 more secondary outcomes
Study Arms (4)
gBRCAm;
EXPERIMENTALgermline BRCA mutant
sBRCAm and germline BRCA wild type;
EXPERIMENTALsomatic BRCA mutant, germline BRCA wild type
myChoice® HRD positive and BRCAwt;
EXPERIMENTALgenomic instability positive and no BRCA mutation
myChoice® HRD negative and BRCAwt
EXPERIMENTALgenomic instability negative and no BRCA mutation
Interventions
300 mg olaparib tablets taken orally twice daily
Eligibility Criteria
You may qualify if:
- Provision of written signed informed consent prior to any study specific procedures;
- Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer;
- At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
- Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;
- Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression \> 12 months after the end of the last platinum-based chemotherapy);
- Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment;
- ECOG performance status 0 to 1;
- Subjects must have a life expectancy greater than or equal to 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;
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
- Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.
You may not qualify if:
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
- Previous enrollment in the present study;
- Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
- Any previous treatment with a PARP inhibitor, including olaparib;
- Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
- Other malignancy within the last 5 years (few exceptions apply);
- Resting ECG with clinically significant abnormal findings;
- Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
- Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;
- Concomitant use of known strong or moderate CYP3A inducers;
- Persistent toxicities (\> Common Terminology Criteria for Adverse Event \[CTCAE\] grade 2) caused by previous cancer therapy, excluding alopecia;
- Subjects with MDS/AML or with features suggestive of MDS/AML;
- Subjects with pneumonitis or at risk of pneumonitis;
- Subjects with symptomatic uncontrolled brain metastases;
- Major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (47)
Research Site
Anchorage, Alaska, 99508, United States
Research Site
La Jolla, California, 92093, United States
Research Site
Los Angeles, California, 90017, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Hartford, Connecticut, 06102, United States
Research Site
New Haven, Connecticut, 06519, United States
Research Site
Newark, Delaware, 19718, United States
Research Site
South Miami, Florida, 33143, United States
Research Site
Skokie, Illinois, 60077, United States
Research Site
Shreveport, Louisiana, 71103, United States
Research Site
Silver Spring, Maryland, 20910, United States
Research Site
Springfield, Massachusetts, 01199, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Minneapolis, Minnesota, 55407, United States
Research Site
Saint Paul, Minnesota, 55125, United States
Research Site
Berkeley Heights, New Jersey, 07922, United States
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
Newark, New Jersey, 07103, United States
Research Site
Teaneck, New Jersey, 07666, United States
Research Site
New York, New York, 10021, United States
Research Site
New York, New York, 10032, United States
Research Site
New York, New York, 10065, United States
Research Site
The Bronx, New York, 10461, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Portland, Oregon, 97227, United States
Research Site
Abington, Pennsylvania, 19001, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Pittsburgh, Pennsylvania, 15224, United States
Research Site
Providence, Rhode Island, 02905, United States
Research Site
Germantown, Tennessee, 38138, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Annandale, Virginia, 22003, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Vancouver, British Columbia, VSZ 4E6, Canada
Research Site
Winnipeg, Manitoba, R3E 0V9, Canada
Research Site
Halifax, Nova Scotia, B3H 1V7, Canada
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Kingston, Ontario, K7L 2V7, Canada
Research Site
Mississauga, Ontario, L5M 2N1, Canada
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Montreal, Quebec, H1T 2M4, Canada
Research Site
Montreal, Quebec, H2X 0A9, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (1)
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.
PMID: 39695768DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 4, 2016
First Posted
December 6, 2016
Study Start
December 22, 2016
Primary Completion
December 3, 2020
Study Completion
December 3, 2020
Last Updated
April 13, 2022
Results First Posted
April 13, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.