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This study evaluates the efficacy and safety of Zeprumetostat in combination with Fuzuloparib for the treatment of patients with advanced or recurrent ovarian epithelial carcinoma, with the primary endpoint being Objective Response Rate (ORR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence. Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Drug | Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence. Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of patients achieving tumour volume reduction meeting predetermined criteria (RECIST 1.1) and maintaining this reduction for a specified duration (typically at least four weeks), encompassing both complete response (CR) and partial response (PR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The time from the start of treatment to tumour progression or death from any cause, whichever occurs first. | 24 months |
| Overall Survival | The time from the commencement of treatment to death from any cause. |
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Inclusion Criteria:
Complete Blood Count criteria must be met:
A. Hemoglobin ≥ 80 grams per liter; B. Absolute neutrophil count ≥ 1.5 × 10⁹ per liter; C. Platelet count ≥ 80 × 10⁹ per liter.
Biochemistry criteria must meet the following standards:
A. Total bilirubin < 1.5 times the upper limit of normal; B. Alanine aminotransferase and aspartate aminotransferase < 2.5 times the upper limit of normal, and < 5 times the upper limit of normal for patients with liver metastases; C. Serum creatinine ≤ 1.5 times the upper limit of normal or endogenous creatinine clearance > 60 milliliters per minute (calculated by the Cockcroft-Gault formula); D. Urine protein < 2+ or 24-hour urinary protein quantification < 1 gram.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyan Guo, Doctor | Contact | +86 188 1158 3538 | bysyghy@163.com |
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Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence.
Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur.
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| 36 months |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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