Ovarian CancerNCT03079687
Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
A study testing Olaparib tablets in people with Ovarian Cancer, run by AstraZeneca at 13 sites in United States.
Trial summary
This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Olaparib tablets
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 13 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the program patients must fulfill the following criteria:
- Provision of informed consent prior to any program specific procedures
- Female patients ≥ 18 years of age and has platinum-sensitive relapsed high grade epithelial ovarian, primary peritoneal or fallopian tube cancer
- Patient is in response (complete response or partial response) following platinum-based chemotherapy.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of program treatment.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential.
Who cannot join
- Patients should not enter the program if any of the following exclusion criteria are fulfilled:
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors.
- Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Patient with moderate or severe hepatic impairment.
- Breast feeding women.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Research Site
Albuquerque, New Mexico, 87106
Research Site
Baltimore, Maryland, 21201
Research Site
Cleveland, Ohio, 44195
Research Site
Columbia, Missouri, 65212
Research Site
Duarte, California, 91010
Research Site
Durham, North Carolina, 27710
Research Site
Gainesville, Florida, 32608
Research Site
Newport Beach, California, 92663
Research Site
Portland, Oregon, 97239
Research Site
Rochester, Minnesota, 55905
Research Site
Roseville, California, 95661
Research Site
Scarborough, Maine, 04074
Research Site
Winston-Salem, North Carolina, 27157-1023
About this study
Official title: A Multiple Patient Expanded Access Program for Olaparib Tablets for the Maintenance Treatment Following Response (Complete Response or Partial Response) to Platinum-based Chemotherapy in Patients With Platinum-sensitive Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.
Read the detailed description
The Multiple Patient Expanded Access Program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) following platinum-based chemotherapy. The dose of olaparib tablets is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. Treatment may continue until disease progression, unacceptable toxicity or withdrawal of patient consent. The program will collect observational data only.
- Conditions
- Ovarian Cancer
- Being tested
- Olaparib tablets
- Keywords
- Ovarian cancer, gynaecological cancer, platinum-sensitive disease, platinum-sensitive relapsed, Olaparib, Ovarian Neoplasms, Neoplasms, Ovarian Disease, fallopean tube cancer, primary peritoneal cancer, epithelial ovarian cancer, PARP inhibitors, Poly (ADP-ribose) polymerase inhibitors.
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Ovarian Diseases, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib tabletsDrug
Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079687
- Sponsor's protocol ID
- D0816R00014
- Status last verified
- Oct 2017
- First submitted
- 8 Mar 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Patient Expanded Access Program for Olaparib Tablets for the Maintenance Treatment Following Response (Complete Response or Partial Response) to Platinum-based Chemotherapy in Patients With Platinum-sensitive Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
- ClinicalTrials.gov ID
- NCT03079687
- Acronym / sponsor ID
- D0816R00014
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, gynaecological cancer, platinum-sensitive disease, platinum-sensitive relapsed, Olaparib, Ovarian Neoplasms, Neoplasms, Ovarian Disease
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.
Detailed description
The Multiple Patient Expanded Access Program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) following platinum-based chemotherapy. The dose of olaparib tablets is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. Treatment may continue until disease progression, unacceptable toxicity or withdrawal of patient consent. The program will collect observational data only.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent prior to any program specific procedures
- Female patients ≥ 18 years of age and has platinum-sensitive relapsed high grade epithelial ovarian, primary peritoneal or fallopian tube cancer
- Patient is in response (complete response or partial response) following platinum-based chemotherapy.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of program treatment.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential.
Key exclusion criteria (6 listed)
- Patients should not enter the program if any of the following exclusion criteria are fulfilled:
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors.
- Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Patient with moderate or severe hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olaparib tabletsPatients will receive olaparib tablets 300mg (two 150mg tablets) twice daily. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olaparib tablets in people with Ovarian Cancer, run by AstraZeneca at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.