Ovarian CancerPhase 2NCT05170594
A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer
A Phase 2 study testing Bevacizumab, chemotherapy and Fluzoparib in people with Ovarian Cancer, run by The Second Affiliated Hospital of Shandong First Medical University at 1 site in China.
Trial summary
This study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bevacizumab, chemotherapy and Fluzoparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2021to 30 Jun 2024
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, female;
- Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
- ECOG score was 0-1;
- Expected survival time > 12 weeks;
- Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator;
- Patients not previously treated with PARPi or targeted drugs;
- The patient has taken effective contraceptive measures within 14 days prior to screening and is willing to sign the notification until the last medication No pregnancy plan and voluntary use of effective contraceptive measures within the next 6 months;
- The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent.
Who cannot join
- Known allergy to fluzopalil or study drug components;
- Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered);
- Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial;
- Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives;
- Pregnant or lactating women or subjects who cannot use contraception as required;
- Those who have special requirements on diet and cannot accept uniform diet;
- As judged by the researcher, there are other circumstances that are not suitable for the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
Zhensheng Fang, +86-0538-6236830, sdtatszhenhua@126.com
Haiyan Liu
About this study
Official title: A Prospective Study of Bevacizumab Combined With Fluzoparib, Bevacizumab Combined With Chemotherapy or Fluzoparib Monotherapy in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
This study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.
Read the detailed description
This purpose of this study is to explore efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.Besides the efficacy,we focus on the safety and quality of life in the new treatments.
- Conditions
- Ovarian Cancer
- Being tested
- Bevacizumab, chemotherapy, Fluzoparib
- Keywords
- platinum-resistant, recurrent ovarian cancer, Bevacizumab, Fluzoparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Antiangiogenic drugs
Bevacizumab will be administered at 15mg/kg IV, every 3 weeks
chemotherapyDrug
Also called Non-platinum chemotherapy
The non-platinum chemotherapy regimen will be determined by the investigator.
FluzoparibDrug
Also called PARPi
Fluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab combined with Fluzoparib | Experimental | Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer. Receives: Drug: Bevacizumab; Drug: chemotherapy |
| Bevacizumab combined with chemotherapy | Experimental | Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer. Receives: Drug: Bevacizumab; Drug: chemotherapy |
| Fluzoparib | Experimental | Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer. Receives: Drug: Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Measured: 2 years
Secondary outcomes (3)
Objective remission rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR).
Measured: 2 years
Overall Survival
Time from randomization to death from any cause (for subjects who have been lost to follow-up prior to death, the time of death is usually calculated as the time of last follow-up)
Measured: 2 years
Adverse event Adverse event
It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start24 Dec 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyan Liu, Principal investigator, The Second Affiliated Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170594
- Sponsor's protocol ID
- MT-004
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. doi: 10.1016/j.ygyno.2015.12.020. Epub 2015 Dec 23.
PubMed 26723501Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1.
PubMed 30948273Mellinghoff IK, Chang SM, Jaeckle KA, van den Bent M. Isocitrate Dehydrogenase Mutant Grade II and III Glial Neoplasms. Hematol Oncol Clin North Am. 2022 Feb;36(1):95-111. doi: 10.1016/j.hoc.2021.08.008. Epub 2021 Oct 25.
PubMed 34711457Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Bevacizumab Combined With Fluzoparib, Bevacizumab Combined With Chemotherapy or Fluzoparib Monotherapy in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05170594
- Acronym / sponsor ID
- MT-004
- Conditions
- Ovarian Cancer
- Keywords
- platinum-resistant, recurrent ovarian cancer, Bevacizumab, Fluzoparib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical UniversityUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Dec 2021 (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 study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.
Detailed description
This purpose of this study is to explore efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.Besides the efficacy,we focus on the safety and quality of life in the new treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab combined with Fluzoparib | Experimental | Drug: Bevacizumab, Drug: chemotherapyBevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer. |
| Bevacizumab combined with chemotherapy | Experimental | Drug: Bevacizumab, Drug: chemotherapyBevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer. |
| Fluzoparib | Experimental | Drug: FluzoparibFluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, female;
- Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
- ECOG score was 0-1;
- Expected survival time > 12 weeks;
- Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator;
Key exclusion criteria (7 listed)
- Known allergy to fluzopalil or study drug components;
- Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered);
- Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial;
- Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives;
- Pregnant or lactating women or subjects who cannot use contraception as required;
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 |
|---|---|---|
| BevacizumabAlso: Antiangiogenic drugsBevacizumab will be administered at 15mg/kg IV, every 3 weeks | Drug | Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy |
| chemotherapyAlso: Non-platinum chemotherapyThe non-platinum chemotherapy regimen will be determined by the investigator. | Drug | Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy |
| FluzoparibAlso: PARPiFluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable | Drug | Fluzoparib |
Primary outcome
Progression-Free-Survival
Time frame: 2 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
3 secondary outcomes
Objective remission rate
Time frame: 2 years
Overall Survival
Time frame: 2 years
Adverse event Adverse event
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 26723501Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. doi: 10.1016/j.ygyno.2015.12.020. Epub 2015 Dec 23.
- Background: PubMed 30948273Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1.
- Background: PubMed 34711457Mellinghoff IK, Chang SM, Jaeckle KA, van den Bent M. Isocitrate Dehydrogenase Mutant Grade II and III Glial Neoplasms. Hematol Oncol Clin North Am. 2022 Feb;36(1):95-111. doi: 10.1016/j.hoc.2021.08.008. Epub 2021 Oct 25.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Individual participant dataSharing planned: No
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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.
Haiyan Liu principal investigator
The Second Affiliated Hospital of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, chemotherapy and Fluzoparib in people with Ovarian Cancer, run by The Second Affiliated Hospital of Shandong First Medical University 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 8 inclusion and 7 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 28 Dec 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yue Miao (+86-13854893531, miaoyue0626@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170594, which also lists 4 linked publications.
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 28 Dec 2021.