2026-525382-47-00招募中2 期
A Phase 2 Study of Alisertib in Combination with Paclitaxel in Patients with Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 27
- 主要终点
- Adverse Events (AEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
研究概览
简要总结
Assess the safety and tolerability of various doses of alisertib dosed on Days 1-7 in combination with paclitaxel dosed on Days 1 and 8 of a 21-day cycle.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years at signing of informed consent.
- •Pathologically confirmed SCLC. Note: SCLC must be the primary diagnosis; mixed SCLC is allowed. Patients with transformed SCLC are not eligible.
- •Prior treatment with and progression on or after one platinum-based chemotherapy and an anti-PD-1/PD-L1 immunotherapy, and when clinically appropriate and reasonably accessible through routine clinical care, patients must have received prior treatment with tarlatamab. A total of two prior regimens is allowed. Patients with platinum-sensitive relapse (≥90 days after the last dose of platinum-based chemotherapy) must have received platinum-based retreatment and experienced disease progression on or after treatment, unless platinum-based retreatment was deemed unsuitable for the individual patient. Note: Induction with a platinum-based chemotherapy ± an anti-PD-1/PD-L1 immunotherapy followed by anti-PD-1/PD-L1 maintenance is considered one treatment regimen of therapy.
- •At least one measurable target lesion outside of the central nervous system (CNS) as defined by RECIST v1.
- •Must provide most recent formalin fixed paraffin-embedded (FFPE) tissue biopsy. Archival tissue is acceptable. If archival tissue is unavailable, patient must be willing to provide fresh tissue biopsy.
排除标准
- •Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting.
- •Prior treatment with a taxane, including paclitaxel, in any setting.
- •CNS metastases. Note: Patients with stable, treated brain metastases are eligible if there is no evidence of progression or hemorrhage and are asymptomatic and off steroids for at least 14 days prior to C1D
- •Patients may remain on a stable dose of anti-convulsants.
研究组 & 干预措施
Alisertib Enteric-Coated Tablets
Test
干预措施: Alisertib Enteric-Coated Tablets (Drug)
Paclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Test
干预措施: Paclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
结局指标
主要结局
Adverse Events (AEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Adverse Events (AEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
次要结局
- Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
研究者
Chief Medical Affairs, Regulatory Affairs and Pharmacovigilance Officer
Scientific
Puma Biotechnology Inc.
研究点 (27)
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