Ovarian NeoplasmsNCT05440578
First-line Olaparib Combined With Bevacizumab Maintenance Therapy
An observational study of Ovarian Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- olaparib plus bevacizumab maintenance therapy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with HGSOC who started first-line olaparib plus bevacizumab maintenance therapy from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) will be identified from the electronic medical record system.
Who may be able to join
- Female Patients must be ≥18 years old at diagnosis.
- Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib and plus bevacizumab from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required)
- Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations)
- Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR)
- Patients who were still in CR or PR before receiving maintenance therapy
- Patients who received at least one dose of olaparib plus bevacizumab maintenance therapy within three months after platinum-based chemotherapy and without disease progression
Who cannot join
- Patient with multiple primary cancers as reported in EMR
- Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during olaparib plus bevacizumab maintenance therapy.
- Any previous treatment with PARP inhibitor.
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Patients with symptomatic uncontrolled brain metastases.
- Any other concerns related to decreased efficacy and safety of maintenance therapy.
About this study
Official title: Outcomes of First-line Olaparib Combined With Bevacizumab Maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Real-world Study
Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.
Read the detailed description
The main objective is to evaluate the outcome of olaparib plus bevacizumab combination maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFSrate) We hypothesize that olaparib plus bevacizumab maintenance therapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy.
The secondary objectives are to evaluate the outcomes of olaparib plus bevacizumab maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib plus bevacizumab dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.
- Conditions
- Ovarian Neoplasms
- Being tested
- olaparib plus bevacizumab maintenance therapy
- Keywords
- tBRCA， olaparib，bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olaparib plus bevacizumab maintenance therapyDrug
First-line olaparib plus bevacizumab maintenance therapy initiated from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required).
| Study group | Role | What they receive |
|---|---|---|
| olaparib plus bevacizumab treatment group | olaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China. Receives: Drug: olaparib plus bevacizumab maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-yr PFS rate
the investigator assessed progression-free survival (PFS) at 1 year
Measured: 12 months after date of first dose
Secondary outcomes (4)
2-yr PFS rate
the investigator assessed progression-free survival (PFS) at 2 year
Measured: 24 months after date of first dose
Median PFS
median progression-free survival
Measured: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
mTFST
median Time to First Subsequent Therapy or death
Measured: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Post-progression treatment
The proportion of patients receiving each treatment after first progression through study completion, an average of 1 year
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study startJun 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440578
- Sponsor's protocol ID
- ESR-20-20889-01
- Status last verified
- Jun 2022
- First submitted
- 8 Dec 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of First-line Olaparib Combined With Bevacizumab Maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Real-world Study
- ClinicalTrials.gov ID
- NCT05440578
- Acronym / sponsor ID
- ESR-20-20889-01
- Conditions
- Ovarian Neoplasms
- Keywords
- tBRCA， olaparib，bevacizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Jul 2022 (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.
Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.
Detailed description
The main objective is to evaluate the outcome of olaparib plus bevacizumab combination maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFSrate) We hypothesize that olaparib plus bevacizumab maintenance therapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy.
The secondary objectives are to evaluate the outcomes of olaparib plus bevacizumab maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib plus bevacizumab dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| olaparib plus bevacizumab treatment group | – | Drug: olaparib plus bevacizumab maintenance therapyolaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with HGSOC who started first-line olaparib plus bevacizumab maintenance therapy from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) will be identified from the electronic medical record system.
Key inclusion criteria (6 listed)
- Female Patients must be ≥18 years old at diagnosis.
- Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib and plus bevacizumab from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required)
- Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations)
- Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR)
- Patients who were still in CR or PR before receiving maintenance therapy
Key exclusion criteria (6 listed)
- Patient with multiple primary cancers as reported in EMR
- Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during olaparib plus bevacizumab maintenance therapy.
- Any previous treatment with PARP inhibitor.
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Patients with symptomatic uncontrolled brain metastases.
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 plus bevacizumab maintenance therapyFirst-line olaparib plus bevacizumab maintenance therapy initiated from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required). | Drug | olaparib plus bevacizumab treatment group |
Primary outcome
1-yr PFS rate
Time frame: 12 months after date of first dose
the investigator assessed progression-free survival (PFS) at 1 year
4 secondary outcomes
2-yr PFS rate
Time frame: 24 months after date of first dose
Median PFS
Time frame: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
mTFST
Time frame: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Post-progression treatment
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 1 Jul 2022. 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.
What does the primary outcome measure?
1-yr PFS rate (time frame: 12 months after date of first dose). It is what the study was designed to measure, not a finding.
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 1 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.