Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer

NCT06188455 | Not Yet Recruiting Phase 3

• 1 other identifier: FJ-OC-021
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  To evaluate the efficacy and safety of fluzoparil combined with apatinib for maintenance after platinum-containing chemotherapy in patients with recurrent ovarian cancer by progression-free survival (PFS).

  up to12 months

Secondary Outcomes (2)

• ORR

  up to 12 months

• OS

  up to 24 months

Study Arms (1)

Fuzuloparib With Apatinib Mesylate Tablets

EXPERIMENTAL

Drug: Fluzoparib Capsules; Drug: Apatinib Mesylate Tablets

Interventions

Fluzoparib Capsules DRUG

Oral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice daily

Fuzuloparib With Apatinib Mesylate Tablets

Apatinib Mesylate Tablets DRUG

Oral administration of 250 mg each time, 1 tablet/time (250 mg/tablet)

Fuzuloparib With Apatinib Mesylate Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 ≤75 years old, female; 2. Pathological (including histological) evidence of ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer (ovarian cancer); 3. Received first-line platinum drug chemotherapy in the past, the curative effect during the last treatment with platinum regimen (from the start of treatment to within 1 month after the last administration) was non-PD, and the recurrence/progression (platinum resistance) within 6 months after the end of treatment; Or recurrence or progression (platinum-sensitive) ≥6 months after the end of the last platinum-containing treatment; CR/PR/SD after at least 4 cycles of chemotherapy again; 4. According to RECIST1.1 criteria, the patient had at least one target lesion with measurable diameter (tumor lesion with CT scan length ≥10mm, lymph node lesion with CT scan short diameter ≥15mm, and scanning layer thickness 5mm); 5. ECOG PS 0-1 score; 6. Major organs function normally and meet the following criteria:
• The standard of blood routine examination must meet: (no blood transfusion within 14 days)
• HB≥100g/L,
• WBC≥3×109/L
• ANC≥1.5×109/L,
• PLT≥100×109/L;
• Biochemical examination shall meet the following standards:
• BIL ≤1.5 times upper limit of normal value (ULN);
• ALT and AST≤2.5×ULN, and ALT and AST≤5×ULN in patients with liver metastasis;
• Serum Cr≤1.5×ULN. 7. International Standardized ratio (INR) OR prothrombin time (PT), activated partial thrombin activity time (aPTT)≤1.5 × ULN, unless the patient is receiving anticoagulant therapy, as long as PT or aPTT is within the therapeutic range of the anticoagulant drug intended to be used; 8. No serious heart, lung, liver, kidney disorders; 9. Women of reproductive age must undergo a pregnancy test (serological) within 7 days prior to enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug; 10. The expected overall survival ≥6 months, post-treatment survival ≥3 months; 11. Sign a written informed consent and be able to comply with the visit and related procedures specified in the program.

You may not qualify if:

• Other clinical drug experiments in which other experimental drugs are used at the same time as the study;
• Other cancer treatments, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbiological therapy, traditional Chinese medicine therapy and other experimental therapies, were used in conjunction with this study;
• Patients who are known to be allergic to fluzoparil or to active or inactive components of the drug with a similar chemical structure;
• Patients who are known to be allergic to Apatinib or to active or inactive components of the drug with a similar chemical structure;
• Inability to swallow oral medications and any gastrointestinal disorders that may interfere with study drug absorption and metabolism, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
• Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical manifestations of spinal cord compression;
• The subject has had other malignant diseases in the past 3 years, except cutaneous squamous cell carcinoma, basal-like carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix;
• The patient has a prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
• Patients with clinical symptoms or diseases that are not well controlled, such as: (1) NYHA2 or above cardiac dysfunction, (2) unstable angina pectoris, (3) acute myocardial infarction occurred within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc\>470ms;
• Any bleeding event with a severe CTCAE 5.0 rating of 2 or more occurring within 4 weeks prior to the initial trial administration;
• People with hypertension who are not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
• Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, institutionalized pneumonia, drug-induced pneumonia, or active pneumonia shown by CT during screening;
• Patients with abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds) who have bleeding tendencies or are receiving thrombolytic or anticoagulant therapy (including but not limited to patients requiring long-term anticoagulant therapy) are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial;
• Diagnosis of patients with deep vein thrombosis (except intermuscular vein thrombosis);

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fluzoparib; apatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 3, 2024

Record last verified: 2023-10