NCT07214779招募中3 期
A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
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
- 466
- 试验地点
- 215
- 主要终点
- Progression-Free Survival (PFS) by BICR
研究概览
简要总结
The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- •Have platinum-resistant disease.
- •Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.
- •Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
- •Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
- •Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
- •Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
- •Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
- •Measurable disease per RECIST v1.1.
排除标准
- •Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
- •Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
- •Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
- •Known active CNS metastases and/or carcinomatous meningitis.
- •Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
- •Clinically significant gastrointestinal abnormalities.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Treatment Group B (TGB)
Experimental
Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.
干预措施: Investigator's choice of chemotherapy (Drug)
Treatment Group A (TGA)
Experimental
INCB123667 at the protocol-defined dose.
干预措施: INCB123667 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) by BICR
时间窗: Up to 2 years
Defined as the time from the date of randomization until the earliest date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
Overall Survival (OS)
时间窗: Up to 2 years
Defined as the time from the date of randomization until death due to any cause.
次要结局
- Objective response by BICR(Up to 2 years)
- Duration of Response (DOR) by BICR(Up to 2 years)
- Progression-Free Survival (PFS) by investigator(Up to 2 years)
- Objective response by investigator(Up to 2 years)
- DOR by investigator(Up to 2 years)
- Treatment Emergent Adverse Events (TEAEs)(Up to 2 years and 30 days)
- TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment(Up to 2 years and 30 days)
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit(Up to 2 years)
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 28 (C28) score at each postbaseline visit(Up to 2 years)
- Change from baseline in EQ-5D-5L score at each postbaseline visit(Up to 2 years)
研究者
研究点 (215)
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