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Ovarian CancerPhase 2NCT05585281

A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

A Phase 2 study testing Fluzoparib and QL1101 in people with Ovarian Cancer, run by Yongpeng Wang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Fluzoparib and QL1101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
27 Jul 2023to 22 Dec 2025
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • I-1.Patients voluntarily participated in this study and signed the informed consent.
  • I-2.Age 18-70 years, female. I-3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. I-4.Patients with newly diagnosed, histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer（FIGO Stage III or IV）.
  • I-5.Completion of ideal tumor cytoreduction (either intermediate cytoreduction or initial cytoreduction).
  • I-6.First line therapy with platinum-taxane chemotherapy consists of a minimum of 6 treatment cycles and a maximum of 8 treatment cycles in patients who have achieved complete response (CR) or partial response (PR).
  • I-7.Patients who must receive at least 4 cycles of platinum-based therapy if non-hematologic toxicity specifically associated with platinum-based therapy (i.e., neurotoxicity, hypersensitivity reactions, etc.) necessitates early termination.
  • I-8.Those who can swallow tablets normally.
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  • I-9.The functions of vital organs meet the following requirements:
  • Absolute neutrophil count ≥ 1.5 × 109/L;
  • Platelets ≥ 90 × 109/L;
  • Hemoglobin ≥ 100 g/L;
  • Serum albumin ≥ 30 g/L;
  • Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN);
  • ALT and AST ≤ 3 × ULN; in case of liver metastases, ALT and AST < 5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN;
  • International normalized ratio (INR) ≤1.5 and activated prothrombin time (aptt) ≤1.5× ULN in patients not receiving anticoagulants.
  • I-10.Maintenance therapy is initiated within 8 weeks, counting from the last day of the last chemotherapy session, and all major toxicities from prior chemotherapy must be resolved by maintenance therapy to CTC Adverse Event grade 1 or better (except alopecia and peripheral neuropathy).
  • I-11.Normal blood pressure or adequately treated and controlled hypertension (systolic blood pressure ≤ 140 mmHg and/or diastolic blood pressure ≤ 90 mmHg) .
  • I-12.Willingness to undergo genetic testing: including germline and/or systemic BRCA1/2 testing, HRD testing, etc.
  • I-13.Non-surgical sterilization or female patients of childbearing age need to use two medically approved contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; non-surgical sterilized female patients of childbearing age must have a negative serum human chorionic gonadotropin(HCG) test within 72 hours before the first dose, and must be non-lactating; for male patients whose partners are women of childbearing age, two effective methods of contraception should be used during the study treatment period and for 3 months after the end of the study treatment period.

Who cannot join

  • E-1.Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
  • E-2.Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
  • E-3.Clinical evidence of stable disease or progressive disease following treatment at the end of the first-line chemotherapy.
  • E-4.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)Patients with a history of localized malignancy diagnosed over 5 years ago, who have completed all treatment and have no recurrent or metastatic disease prior to enrollment may be enrolled.
  • E-5.Patients with myelodysplastic syndrome/acute myeloid leukemia history. E-6.Patients receiving radiotherapy within 6 weeks or Major surgery within 4 weeks prior to study treatment.
  • E-7.Any previous treatment with PARP inhibitor, including fluzoparib. E-8.Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
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  • E-9.Clinically significant (e.g. active) cardiovascular disease, including:
  • New York Heart Association (NYHA) grade 2 or higher heart failure.
  • Unstable angina pectoris.
  • Myocardial infarction within 1 year.
  • Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • Qtc>470ms. E-10.Patients who underwent cytoreductive surgery more than once before maintenance treatment（Patients who were considered unresectable at diagnosis only received biopsy or ovarian resection, and then continued chemotherapy for intermediate cytoreductive surgery may be enrolled）.
  • E-11.Patients who have received chemotherapy for abdominal or pelvic tumors, including those who received chemotherapy for early diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • E-12.Patients with synchronous primary endometrial cancer unless both of the following two criteria are met:
  • Sage < 2.
  • Less than 60 years old at the time of diagnosis of endometrial cancer with stage ia or ib grade 1 or 2, or stage ia grade 3 endometrioid adenocarcinoma or ≥ 60 years old at the time of diagnosis of endometrial cancer with stage ia grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
  • E-13.Pregnant or lactating women. E-14.Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin, and nelfinavir.
  • E-15.History of allergic reactions to carboplatin. E-16.Participation in another clinical study with an investigational product.

Trial locations and contacts

1 site in 1 country.

Yongpeng Wang contact

+8613940426817

w18900917191@126.com

China1 site, 1 recruiting

  • Yongpeng Wang

    Shenyang

    Yongpeng Wang, +8613940426817, w18900917191@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib Combined With QL1101 for Maintenance Treatment in Patients With Advanced Epithelial Ovarian Cancer Following Response After First-line Platinum-containing Chemotherapy

This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.

Conditions
Ovarian Cancer
Being tested
Fluzoparib, QL1101
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluzoparibDrug

    Fluzoparib Orally twice daily

  • QL1101Biological

    Maintenance QL1101 7.5 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. QL1101 will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of QL1101 received with chemotherapy.

Study groups in NCT05585281
Study groupRoleWhat they receive
Participants receiving Fluzoparib+ QL1101ExperimentalParticipants will be administered QL1101 7.5 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Fluzoparib will be administered orally twice daily continuously throughout each 21-day cycle. On Day 1 of each cycle, fluzoparib will be administered upon completion of QL1101 infusion. The starting dose of fluzoparib will be based on the participant's Baseline actual body weight or platelet count.
Receives: Drug: Fluzoparib; Biological: QL1101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free-Survival(PFS)

    PFS by investigator's assessment

    Measured: up to 2 years

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.

    Measured: up to 2 years

  2. Second Progression Free Survival（PFS2）

    Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first. The impact of this study's maintenance regimen on patient follow-up was determined by assessing the time from enrollment to second progression (PFS2), or the purpose of the PFS2 analysis was to demonstrate whether maintenance treatment could reduce the benefit provided by follow-up.

    Measured: up to 2 years

  3. Time to start of first subsequent therapy or death（TFST）

    The evaluation of the efficacy of first-line platinum-based chemotherapy and maintenance therapy by assessing the time to first follow-up or death, in addition to the similar assessment role as for PFS, allows evaluation of whether the regimen has an impact on follow-up and, if follow-up is delayed, on PFS2 and OS.

    Measured: up to 2 years

  4. Health-related quality of life（HRQoL）

    To evaluate the effects of this trial protocol on health-related quality of life (HRQoL) in patients with high-risk advanced epithelial ovarian cancer as assessed by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Ovary (FACT-O).The TOI ranges from 0 to 100, with higher scores associated with higher HRQoL.

    Measured: up to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start27 Jul 2023 (estimated)
  3. Primary completion7 Nov 2025 (estimated)
  4. Study completion22 Dec 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585281
Sponsor's protocol ID
20220501
Status last verified
Jul 2023
First submitted
12 Oct 2022
Last updated
28 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib and QL1101 in people with Ovarian Cancer, run by Yongpeng Wang 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 19 inclusion and 18 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 Jul 2023. 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 Yongpeng Wang (+8613940426817, w18900917191@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(PFS) (time frame: up to 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 NCT05585281.

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 Jul 2023.

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