Recurrent Ovarian CancerNCT03025867
Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
A study testing Niraparib in people with Recurrent Ovarian Cancer, run by Tesaro, Inc..
Trial summary
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- Niraparib
- How many people
- Not given
- Where
- No sites listed yet
- 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 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Completion of at least 2 previous courses of platinum-containing chemotherapy.
- Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy
- Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]
- Patients previously treated with PARP inhibitors are eligible
- Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1
Show all 10Show fewer
- Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL]
- Able to take oral medications
- Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib
- Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy
Who cannot join
- Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
- Known hypersensitivity to the components of niraparib
- Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
- Patient has uncontrolled hypertension
About this study
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.
This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).
To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.
Read the detailed description
If a patient qualifies for participation in an ongoing niraparib clinical trial or is already participating in a niraparib clinical trial, she will not be able to participate in the EAP.
Ongoing clinical trials for niraparib include:
- A Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial, NCT # 02655016)
- A Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial, NCT # 02354586)
- A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- Niraparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- 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
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025867
- Sponsor's protocol ID
- 3000-07-001
- Status last verified
- Apr 2017
- First submitted
- 16 Jan 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03025867
- Acronym / sponsor ID
- 3000-07-001
- Conditions
- Recurrent Ovarian Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- First posted
- 20 Jan 2017 (estimated)
- 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 expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.
This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).
To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.
Detailed description
If a patient qualifies for participation in an ongoing niraparib clinical trial or is already participating in a niraparib clinical trial, she will not be able to participate in the EAP.
Ongoing clinical trials for niraparib include:
- A Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial, NCT # 02655016)
- A Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial, NCT # 02354586)
- A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Completion of at least 2 previous courses of platinum-containing chemotherapy.
- Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy
- Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]
- Patients previously treated with PARP inhibitors are eligible
Key exclusion criteria (4 listed)
- Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
- Known hypersensitivity to the components of niraparib
- Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
- Patient has uncontrolled hypertension
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 |
|---|---|---|
| Niraparib | 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 17 Apr 2017.
Related trials for Recurrent Ovarian Cancer
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Niraparib in people with Recurrent Ovarian Cancer, run by Tesaro, Inc..
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 10 inclusion and 4 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 17 Apr 2017.