2025-524641-27-00招募中3 期
A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 179
- 试验地点
- 33
- 主要终点
- Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator
研究概览
简要总结
Evaluate PFS in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-screening Inclusion criteria: Provision of evaluable, most recent FFPE tumor tissue block (preferably collected within the previous 3 years; if multiple tissue blocks are available, the most recently collected tissue sample is to be submitted) or 15 serially sectioned slides freshly cut from an FFPE block.
- •Prior mirvetuximab is required if approved and available for eligible subjects
- •Adequate hematologic and organ function during the Screening Period For the complete Inclusion Criteria, please refer to the study protocol
- •Provision of signed Main ICF
- •Female Age ≥18 years (or age of majority in local region) at the time of informed consent.
- •Performance status: Eastern Cooperative Oncology Group (ECOG) score of ≤ 1
- •Histologically or cytologically diagnosed high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- •Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1
- •The subject’s tumor tissue must be positive for cyclin E1 protein expression per the Sponsor’s clinically validated, in vitro diagnostic assay
- •Subject must have platinum-resistant disease
- •Subjects must have received 1-3 prior lines of therapy (up to 4 if prior mirvetuximab )
排除标准
- •Platinum refractory disease (in front line therapy)
- •Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
- •Any of the following treatment interventions within the specified time frame before randomization: a. Hospitalization for any reason within 14 days b. Major surgery within 28 days before randomization and any preplanned major surgery scheduled during the study treatment period c. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives d. Radiation therapy within 21 days; however, if the radiation portal covered ≤ 5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy e. Autologous or allogeneic stem cell transplant within 3 months f. Current use of any other investigational drug therapy < 28 days or 5 half-lives
- •Inability to discontinue treatment with prescription or nonprescription drugs that are specified in the protocol.
- •Inability to discontinue any of the following: a. consumption of food and herbal supplements specified in the protocol at least 14 days before C1D1 b. ongoing requirement for (or anticipated future need of) a prohibited therapy, food, or supplement
- •Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or PKMYT1 inhibitor.
- •A serious illness or medical conditions, listed in study protocol
- •Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation). For the complete Exclusion Criteria, please refer to the study protocol
研究组 & 干预措施
GEMCITABINE
Comparator
干预措施: GEMCITABINE (Drug)
PACLITAXEL
Comparator
干预措施: PACLITAXEL (Drug)
Azenosertib (also known as ZN-c3; KP-2638), Azenosertib (also known as ZN-c3; KP-2638)
Test
干预措施: Azenosertib (also known as ZN-c3; KP-2638) (Drug)
Akynzeo 300 mg/0.5 mg hard capsules
Auxiliary
干预措施: Akynzeo 300 mg/0.5 mg hard capsules (Drug)
DOXORUBICIN
Comparator
干预措施: DOXORUBICIN (Drug)
TOPOTECAN
Comparator
干预措施: TOPOTECAN (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator
Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator
次要结局
- Key secondary endpoint: Overall Survival (OS)
- Key secondary endpoint: Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator
- Key secondary endpoint: Change from baseline in the following: • Abdominal/gastrointestinal symptoms as measured by EORTC-QLQ-OV28 (Items 31 to 36) • Remaining PRO symptom scales as measured by EORTC-QLQ-OV28 (Items 37 to 49) • Global Health Status and QOL as measured by EORTC-QLQ-C30 (Items 29 and 30) and EQ-5D-5L VAS
- Additional Secondary Endpoint: PFS, ORR, and Duration Of Response (DOR) as defined by RECIST v1.1 and as assessed by BICR • DOR as defined by RECIST v1.1 and as assessed by Investigator • CA-125 response as defined by GCIG criteria • PFS2
- Additional Secondary Endpoint: TEAEs graded according to NCI-CTCAE v5.0, dose interruptions, dose reductions, and permanent discontinuations of study treatment
研究者
Head of Medical Affairs
Scientific
K-Group Beta Inc.
研究点 (33)
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