Ovarian CancerNCT05206890
A Non-interventional Registry Study of Fluzoparib in the Treatment of Ovarian Cancer
An observational study of Ovarian Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- fluzoparib monotherapy or combination therapy
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2022to 31 Dec 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use Fluzoparibb at the time of enrollment in this study
Who may be able to join
- Sign informed consent and voluntarily join the study;
- Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;
- ≥ 18 years old;
- The investigator determined that the patient could receive fluzoparib monotherapy or combination therapy;
- For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of fluzoparib
Who cannot join
- There is evidence that the patient is a pregnant or lactating woman;
- Participating in any research with intervention measures other than routine clinical practice; 3. The researcher judges other situations that are not suitable for inclusion in the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qinglei Gao, PhD, MD, +86-13871127473, qingleigao@hotmail.com
Qinglei Gao, PhD, MD
About this study
Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis.
This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.
Read the detailed description
Ovarian cancer is one of the most serious malignant tumors that threaten women's health. The incidence rate is third place in the female reproductive system malignant tumors. The mortality rate ranks the first in gynecologic malignancies, and most of them are advanced at the time of diagnosis. The initial treatment of ovarian cancer is mainly surgery and adjuvant chemotherapy. Although most patients can obtain clinical remission after initial treatment, 70% of patients still relapse within 3 years. Therefore, finding effective drugs to prolong the chemotherapy-free interval and exploring comprehensive treatment schemes to prolong survival is the key to treatment.
In recent years, the advent of poly adenosine diphosphate ribose polymerase inhibitors has brought significant changes to the treatment of ovarian cancer. A series of high-level evidence-based medical evidence shows that the application of PARP inhibitors after complete and partial remission of initial treatment or platinum-sensitive recurrence treatment can significantly prolong the progression-free survival time of ovarian cancer patients, Maintenance therapy has become a new model for the treatment of ovarian cancer. At the same time, PARP inhibitors have been approved for posterior line treatment of ovarian cancer. At present, PARP inhibitors have been widely used in clinics and become an important cornerstone of the comprehensive treatment of ovarian cancer.
Fzocus-2 study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study of fluzoparib in the maintenance treatment of platinum-sensitive recurrent ovarian cancer. The preliminary results were published on the American Society of Gynecological Oncology (SGO) in 2021. A total of 252 patients were included in the study and were treated with fluzoparib (n = 167) or placebo (n = 85). The median follow-up time was 8.5 months. The population-wide data assessed by bIRC showed that the median PFS data were not mature. According to the Kaplan Meier curve, fluzoparib could significantly prolong the PFS (12.9 months: 5.5 months) and reduce the risk of disease progression or death by 75%.
Fzocus-3 is a phase IB study of fluzoparib approved for marketing, which included platinum-sensitive recurrent ovarian cancer patients with germline BRCA mutation who had previously received ≥ 3-line treatment. The objective remission rate of single-drug treatment is as high as 69.9%, and the median progression-free survival time is 12.0 months. It is well comparable with similar drugs and has good safety.
Fluzoparib was approved for the treatment of germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer in December 2020 and maintenance treatment of platinum-sensitive recurrent ovarian cancer in June 2021. A number of studies on fluzoparib in the field of ovarian cancer are also underway. It is urgent to obtain the real-world data of fluzoparib in the field of ovarian cancer in China. This study will collect information on the baseline characteristics, treatment, and management of ovarian cancer provided in the real world to illustrate the safety and effectiveness of fluzoparib in the treatment of ovarian cancer under the conditions of real clinical practice. It may also include various subgroups of patients with ovarian cancer, which are not involved in the existing phase III registered studies, In order to better understand and explore the use of PARP inhibitors in some patient subgroups and the treatment mode and effect of PARP inhibitors in the treatment of this disease.
- Conditions
- Ovarian Cancer
- Being tested
- fluzoparib monotherapy or combination therapy
- Keywords
- real world study
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluzoparib monotherapy or combination therapyDrug
patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy
| Study group | Role | What they receive |
|---|---|---|
| fluzoparib treatment | patients with Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy Receives: Drug: fluzoparib monotherapy or combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ≥ grade 3 Hematology related adverse event according to NCI CTCAE v5.0
the safety of fluzoparib in ovarian cancer under real-world conditions, especially Incidence of Hematology related adverse reactions ≥ grade 3
Measured: 30 days after the last dose of fluzoparib
Secondary outcomes (7)
incidence of other adverse event according to NCI CTCAE v5.0
the occasional or rare adverse events of fluzoparib in ovarian cancer under real-world conditions
Measured: 30 days after the last dose of fluzoparib
overall survival (OS)
Overall survival, defined as time from first administration fluzoparib to documented death. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of overall survival (OS) in patients with Ovarian Cancer. Patients will be followed up once 3-6 months at least
Measured: 6 years
Progression free survival (PFS)
Progression-free survival, defined as time from first administration fluzoparib to documented disease progression or death from any cause after baseline, whichever occurs first;. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of progression free survival (PFS) in patients with Ovarian Cancer. Patients will be followed up once 3-6 months at least.
Measured: 6 years
Objective Response Rate (ORR)
Objective Response Rate, defined as percentage of patients with complete or partial response according to local assessments. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of objective response rate (ORR) in patients with Ovarian Cancer. Patients will be followed up once 12 weeks at least.
Measured: 6 years
Disease Control Rate (DCR)
Disease Control Rate, defined as percentage of patients with complete or partial response or stable disease according to local assessments. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of disease control rate (DCR) in patients with Ovarian Cancer. Patients will be followed up once 12 weeks at least.
Measured: 6 years
Duration Of Therapy（DOT）
Duration Of Therapy, defined as the time from first administration fluzoparib to the permanent cessation of fluzoparib (including death).
Measured: 6 years
Tumor marker expression level
Measurements of tumor biomarkers, such as : CA125, HRD, BRCA, etc.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start14 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2032 (estimated)
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 Tongji HospitalThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 490 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Cancer Hospital of Xinjiang Medical University, First Affiliated Hospital Xi'an Jiaotong University, Qingyuan People's Hospital, Zhejiang University, Panzhihua Central Hospital, Liangshan First People's Hospital, Guang'an people's hospital of Sichuan province, Affiliated Hospital of North Sichuan Medical College, Cancer Hospital of Guizhou Province, Guizhou International General Hospital, Yichang Central People's Hospital, Wuhan Fourth Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206890
- Sponsor's protocol ID
- 2022-TJ-FLU
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Registry Study of Fluzoparib in the Treatment of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05206890
- Acronym / sponsor ID
- 2022-TJ-FLU
- Conditions
- Ovarian Cancer
- Keywords
- real world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Cancer Hospital of Xinjiang Medical University, First Affiliated Hospital Xi'an Jiaotong University, Qingyuan People's Hospital, Zhejiang University, Panzhihua Central Hospital, Liangshan First People's Hospital, Guang'an people's hospital of Sichuan province, Affiliated Hospital of North Sichuan Medical College, Cancer Hospital of Guizhou Province, Guizhou International General Hospital, Yichang Central People's Hospital, Wuhan Fourth Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 25 Jan 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.
Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis.
This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.
Detailed description
Ovarian cancer is one of the most serious malignant tumors that threaten women's health. The incidence rate is third place in the female reproductive system malignant tumors. The mortality rate ranks the first in gynecologic malignancies, and most of them are advanced at the time of diagnosis. The initial treatment of ovarian cancer is mainly surgery and adjuvant chemotherapy. Although most patients can obtain clinical remission after initial treatment, 70% of patients still relapse within 3 years. Therefore, finding effective drugs to prolong the chemotherapy-free interval and exploring comprehensive treatment schemes to prolong survival is the key to treatment.
In recent years, the advent of poly adenosine diphosphate ribose polymerase inhibitors has brought significant changes to the treatment of ovarian cancer. A series of high-level evidence-based medical evidence shows that the application of PARP inhibitors after complete and partial remission of initial treatment or platinum-sensitive recurrence treatment can significantly prolong the progression-free survival time of ovarian cancer patients, Maintenance therapy has become a new model for the treatment of ovarian cancer. At the same time, PARP inhibitors have been approved for posterior line treatment of ovarian cancer. At present, PARP inhibitors have been widely used in clinics and become an important cornerstone of the comprehensive treatment of ovarian cancer.
Fzocus-2 study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study of fluzoparib in the maintenance treatment of platinum-sensitive recurrent ovarian cancer. The preliminary results were published on the American Society of Gynecological Oncology (SGO) in 2021. A total of 252 patients were included in the study and were treated with fluzoparib (n = 167) or placebo (n = 85). The median follow-up time was 8.5 months. The population-wide data assessed by bIRC showed that the median PFS data were not mature. According to the Kaplan Meier curve, fluzoparib could significantly prolong the PFS (12.9 months: 5.5 months) and reduce the risk of disease progression or death by 75%.
Fzocus-3 is a phase IB study of fluzoparib approved for marketing, which included platinum-sensitive recurrent ovarian cancer patients with germline BRCA mutation who had previously received ≥ 3-line treatment. The objective remission rate of single-drug treatment is as high as 69.9%, and the median progression-free survival time is 12.0 months. It is well comparable with similar drugs and has good safety.
Fluzoparib was approved for the treatment of germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer in December 2020 and maintenance treatment of platinum-sensitive recurrent ovarian cancer in June 2021. A number of studies on fluzoparib in the field of ovarian cancer are also underway. It is urgent to obtain the real-world data of fluzoparib in the field of ovarian cancer in China. This study will collect information on the baseline characteristics, treatment, and management of ovarian cancer provided in the real world to illustrate the safety and effectiveness of fluzoparib in the treatment of ovarian cancer under the conditions of real clinical practice. It may also include various subgroups of patients with ovarian cancer, which are not involved in the existing phase III registered studies, In order to better understand and explore the use of PARP inhibitors in some patient subgroups and the treatment mode and effect of PARP inhibitors in the treatment of this disease.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluzoparib treatment | – | Drug: fluzoparib monotherapy or combination therapypatients with Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use Fluzoparibb at the time of enrollment in this study
Key inclusion criteria (5 listed)
- Sign informed consent and voluntarily join the study;
- Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;
- ≥ 18 years old;
- The investigator determined that the patient could receive fluzoparib monotherapy or combination therapy;
- For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of fluzoparib
Key exclusion criteria (2 listed)
- There is evidence that the patient is a pregnant or lactating woman;
- Participating in any research with intervention measures other than routine clinical practice; 3. The researcher judges other situations that are not suitable for inclusion in the study;
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 |
|---|---|---|
| fluzoparib monotherapy or combination therapypatients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy | Drug | fluzoparib treatment |
Primary outcome
incidence of ≥ grade 3 Hematology related adverse event according to NCI CTCAE v5.0
Time frame: 30 days after the last dose of fluzoparib
the safety of fluzoparib in ovarian cancer under real-world conditions, especially Incidence of Hematology related adverse reactions ≥ grade 3
7 secondary outcomes
incidence of other adverse event according to NCI CTCAE v5.0
Time frame: 30 days after the last dose of fluzoparib
overall survival (OS)
Time frame: 6 years
Progression free survival (PFS)
Time frame: 6 years
Objective Response Rate (ORR)
Time frame: 6 years
Disease Control Rate (DCR)
Time frame: 6 years
Duration Of Therapy（DOT）
Time frame: 6 years
Tumor marker expression level
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Tongji Hospital at 1 site in China.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of ≥ grade 3 Hematology related adverse event according to NCI CTCAE v5.0 (time frame: 30 days after the last dose of fluzoparib). 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 26 Jan 2022.