预约演示
更新于：2025-01-06
Trilaciclib Dihydrochloride
盐酸曲拉西利
更新于：2025-01-06
概要
基本信息
药物类型 小分子化药 |
别名 Trilaciclib、Trilaciclib hydrochloride、G1T 28 + [4] |
作用机制 CDK4抑制剂(细胞周期蛋白依赖性激酶4抑制剂)、CDK6抑制剂(细胞周期蛋白依赖性激酶6抑制剂) |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-02-12), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (中国)、附条件批准 (中国) |
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结构/序列
分子式C24H32Cl2N8O |
InChIKeyBRCYOXKEDFAUSA-UHFFFAOYSA-N |
CAS号1977495-97-8 |
关联
50
项与 盐酸曲拉西利 相关的临床试验NCT06714266
A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Receiving Either Single Chemotherapy or Chemotherapy Combined with Immunotherapy/targeted Therapy.
ChiCTR2400093139
A real-world study on the efficacy and safety of Trilaciclib in bone marrow protection before chemotherapy for advanced solid tumors
NCT06714383
A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
100 项与 盐酸曲拉西利 相关的临床结果
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100 项与 盐酸曲拉西利 相关的转化医学
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100 项与 盐酸曲拉西利 相关的专利（医药）
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60
项与 盐酸曲拉西利 相关的文献（医药）2024-11-01Journal of Thoracic Disease
Myeloprotection effects of trilaciclib in Chinese patients with extensive stage small cell lung cancer (ES-SCLC) receiving chemotherapy—a real-world study
Article
作者: Liu, Lirong ; Chen, Yongxing ; Yang, Chen ; Meng, Chong ; Chen, Tao ; Liu, Kai
Background:
Trilaciclib, an intravenous short acting cyclin-dependent kinase 4/6 inhibitor, has been approved for the prevention of chemotherapy-induced myelosuppression (CIM) in patients with extensive stage small cell lung cancer (ES-SCLC) receiving platinum/etoposide (EP) or topotecan (TPT)-based therapy in United States (US) since February 2021. Trilaciclib use received the priority review and approval in a real-world setting in China. This study thus aimed to collect real-world data and evaluate the protective effect of trilaciclib on CIM in Chinese patients with ES-SCLC.
Methods:
This single-arm, noninterventional real world study invited all patients with ES-SCLC who received trilaciclib with the platinum and etoposide ± anti-programmed cell death ligand-1 [anti-PD-(L)1] antibodies (EP group) or trilaciclib with TPT (TPT group) in Boao, Hainan China to participate in the study. The primary endpoint was the incidence of the severe (grade four) neutropenia (SN), and the secondary endpoints included other myeloprotection effects, safety and anti-tumor activity.
Results:
Between August 2021 and December 2022, a total of 30 patients who received trilaciclib with chemotherapy consented to participate in this real-world study. Among the enrolled patients, 26 patients were treated with EP regimen, of these, 18 patients were combined with anti-PD-(L)1 antibodies, and 4 patients were treated with TPT. The incidence of SN was 6.7%, with one patient each in EP group and TPT group. The incidence of grade three hematological toxicities was 30% (9/30), with 19.2% (5/26) in the EP group, and 100% (4/4) in the TPT group. The incidence of grade four hematological toxicities was 5/30 (16.7%), with 3/26 (11.5%) and 2/4 (50%) in EP and TPT group, respectively. Overall, the incidence of those who received intravenous or oral antibiotics was 6/30 (20%), with 4/26 (15.4%) in the EP group, and 2/4 (50%) in the TPT group. No ≥ grade three adverse events, serious adverse events (SAEs), and adverse events of special interest associated with trilaciclib were reported.
Conclusions:
Trilaciclib decreased the incidence of CIM in Chinese patients when administered prior to an EP-containing regimen [combined with or without PD-(L)1] or TPT for ES-SCLC. The effect of myeloprotection, anti-tumor and safety were all consistent with the studies conducted globally and data from the Chinese Phase three placebo-controlled study (TRACES).
2024-09-01SUPPORTIVE CARE IN CANCER
Trilaciclib use in extensive-stage small cell lung cancer (ES-SCLC): are clinical benefits seen in the real-world setting?
Article
作者: Attwood, Kristopher ; Billias, Christina ; Baron, Jeffrey ; Dy, Grace K ; Dy, Grace K. ; Holdsworth, Allison ; Przespolewski, Eugene ; Elijah, Joseph ; Wang, Katy ; Jain, Prantesh
Abstract:
Background:
Trilaciclib, in comparison to placebo plus carboplatin, etoposide, ± atezolizumab (PEA), has shown significant reductions in incidence of severe neutropenia (SN) among patients with extensive-stage small cell lung cancer (ES-SCLC). Despite these findings, real-world utility remains limited.
Methods:
A single-center quasi-experimental study compared trilaciclib + PEA (PEAT) versus PEA in ES-SCLC patients. The study period ranged from April 1, 2021 to July 31, 2022, for the PEAT recipients and February 1, 2020, to February 28, 2021, for PEA recipients. The primary endpoint evaluated was incidence of SN after cycle 1 and during the treatment period. Secondary endpoints included measures related to myelopreservation and patient outcomes.
Results:
Among 34 PEAT and 44 PEA patients, baseline characteristics were similar, except for a higher median age (69 vs 64 years) and more males (64.7% vs 38.6%) in the PEAT cohort. The PEAT cohort exhibited a lower SN rate (3%) versus the PEA cohort (18%), with statistical significance demonstrated on multivariate analysis (p = 0.015). Additionally, the PEAT cohort also demonstrated significant reductions in red blood cell transfusion requirements (3% vs 23%; p = 0.02), grade 3–4 anemia (6% vs 25%; p = 0.03), and grade 3–4 thrombocytopenia (0% vs 11%, p = 0.045).
Conclusion:
Trilaciclib, in combination with PEA, demonstrated an improvement in the safety profile without compromising survival outcomes in ES-SCLC patients. These findings underscore the potential benefits of incorporating trilaciclib in real-world clinical settings for enhanced patient care.
2024-08-01Journal of clinical pharmacology
Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics
Article
作者: Li, Chao ; Beelen, Andrew ; Dumas, Emily ; Preston, Richard A. ; Marbury, Thomas C.
Abstract:
Trilaciclib is a first‐in‐class, intravenous cyclin‐dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy‐induced myelosuppression in adult patients with extensive‐stage small cell lung cancer receiving a platinum/etoposide‐containing or topotecan‐containing regimen. No dose adjustment is recommended for participants with mild hepatic impairment (HI) based on previous population pharmacokinetic (PK) analysis. This open‐label, parallel‐group study examined the impact of moderate and severe HI on the PK of trilaciclib. The study employed a reduced study design. Participants with moderate (Child–Pugh B, n = 8) and severe (Child–Pugh C, n = 5) HI and matched healthy controls (n = 11) received a single intravenous dose of trilaciclib 100 mg/m2. The unbound fraction of trilaciclib was comparable between the HI groups and the matched healthy control group. The unbound trilaciclib extent of exposure (i.e., area under the concentration‐time curve) in participants with moderate and severe HI was ∼40% and ∼60% higher, respectively, compared with healthy matched controls based on Child–Pugh classification. Ad hoc analysis using National Cancer Institute classification showed similar results. The US Food and Drug Administration‐approved trilaciclib dose of 240 mg/m2 should be reduced by ∼30%, to 170 mg/m2, for patients with moderate or severe HI.
100 项与 盐酸曲拉西利 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 广泛期小细胞肺癌 | 中国 | 2022-07-12 | |
| 化疗引起的骨髓抑制 | 美国 | 2021-02-12 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 三阴性乳腺癌 | 临床3期 | 中国 | 2021-12-07 | |
| 三阴性乳腺癌 | 临床3期 | 中国 | 2021-12-07 | |
| 转移性三阴性乳腺癌 | 临床3期 | 美国 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 中国 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 澳大利亚 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 保加利亚 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 法国 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 格鲁吉亚 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 摩尔多瓦 | 2021-05-14 | |
| 转移性三阴性乳腺癌 | 临床3期 | 波兰 | 2021-05-14 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 326 | (Trilaciclib + FOLFOXIRI/Bevacizumab) | 獵艱廠餘襯範構襯糧蓋(構艱憲製艱築夢構觸獵) = 觸顧構築衊鬱製夢獵範 壓餘鏇遞醖鏇窪糧鬱膚 (鑰窪鬱齋鏇鑰衊網襯廠, 餘壓網膚餘選鑰廠鏇憲 ~ 淵鏇衊淵壓遞廠膚齋範) 更多 | - | 2024-11-26 | ||
Placebo (Placebo + FOLFOXIRI/Bevacizumab) | 獵艱廠餘襯範構襯糧蓋(構艱憲製艱築夢構觸獵) = 鏇遞衊積構選鹹繭鑰淵 壓餘鏇遞醖鏇窪糧鬱膚 (鑰窪鬱齋鏇鑰衊網襯廠, 繭網選構鬱獵窪鑰觸顧 ~ 淵淵簾鏇獵淵簾築範構) 更多 | ||||||
CSCO2024 人工标引  | N/A | 153 | 窪衊積淵廠構構鹽襯鹹(遞醖鹹齋醖餘鹹窪廠積) = 在使用曲拉西利后的首个治疗周期，严重中性粒细胞减少（SN）发生率为 0.8%（1/132），3/4 级血液学毒性发生率为 5.3%（7/132）；在使用曲拉西利后的所有治疗周期，SN 发生率为 3.0%（4/132），3/4 级血液学毒性发生率为 15.2%（20/132）。 構顧醖淵簾廠壓鏇壓繭 (積壓觸憲衊齋簾艱觸製 ) | 积极 | 2024-09-28 | ||
临床2期 | 28 | 繭簾簾鏇繭網憲築簾衊(鏇鏇範繭鹹糧齋鏇艱夢) = None of the 28 patients developed SN or febrile neutropenia (FN) in the first cycle. During treatment, only 1 patient (4%) developed grade 3/4 neutropenia, and no grade 3/4 anemia and ≥ grade 3 thrombocytopenia were observed. Most common adverse events were grade 1/2, and no treatment-related deaths occurred. 齋襯夢積鹽鹽獵鏇夢製 (鏇夢憲網鹹齋選構網選 ) | 积极 | 2024-09-14 | |||
WCLC2024 人工标引 | N/A | 94 | 蓋範蓋遞淵製顧蓋鏇積(觸鹹顧築願築遞鹽願淵) = 鏇製願繭鹽憲蓋積膚夢 鹹淵淵積鏇範鑰糧壓願 (範襯壓齋襯積膚選鹽獵 ) 更多 | 积极 | 2024-09-07 | ||
Control (no Trilaciclib) | 蓋範蓋遞淵製顧蓋鏇積(觸鹹顧築願築遞鹽願淵) = 構積獵齋選繭齋獵鹽遞 鹹淵淵積鏇範鑰糧壓願 (範襯壓齋襯積膚選鹽獵 ) 更多 | ||||||
临床3期 | 95 | (Part I ( Safety run-in and PK Evaluation); Trilaciclib Group) | 鏇鹹獵糧鏇艱壓鹽糧獵(廠簾願顧築襯夢齋網構) = 鑰願鹽觸鹽齋廠憲憲膚 鏇築鹽觸選繭網醖餘憲 (餘範築餘願齋淵遞齋繭, 鹽鏇夢餘鬱觸憲窪淵簾 ~ 鹹繭積鹽窪範憲繭窪窪) 更多 | - | 2024-07-10 | ||
(Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group) | 鏇鹹獵糧鏇艱壓鹽糧獵(廠簾願顧築襯夢齋網構) = 願鑰廠糧鬱鏇窪餘窪範 鏇築鹽觸選繭網醖餘憲 (餘範築餘願齋淵遞齋繭, 糧選獵鹽艱齋夢顧醖襯 ~ 積壓齋願構窪糧顧觸顧) 更多 | ||||||
临床3期 | 187 | 淵鑰遞願築鹽顧簾鑰選(築築艱選鬱顧鏇鹹廠選) = 蓋網顧醖齋鏇築獵選構 廠鏇構艱鏇鬱壓憲衊襯 (願淵簾顧繭繭艱壓網網 ) 未达到 | 不佳 | 2024-06-24 | |||
Placebo+ gemcitabine and carboplatin | 淵鑰遞願築鹽顧簾鑰選(築築艱選鬱顧鏇鹹廠選) = 鏇蓋製鹽範夢鬱夢衊廠 廠鏇構艱鏇鬱壓憲衊襯 (願淵簾顧繭繭艱壓網網 ) 未达到 | ||||||
临床2期 | 三阴性乳腺癌 human epidermal growth factor receptor 2-negative | hormone receptor negative | 30 | 憲願遞繭窪蓋蓋蓋簾鬱(積襯蓋夢夢艱窪鹽艱網) = 齋願遞顧鹽觸窪鏇齋繭 艱獵繭窪網蓋積選艱艱 (獵獵觸繭築製選網願窪, 9.9 ~ 42.3) 更多 | 积极 | 2024-05-24 | ||
临床2期 | 24 | Cylophosphamide+Carboplatin (Investigator discretion)+Trilaciclib+doxorubicin+paclitaxel+Pembrolizumab (Investigator discretion) | 選廠齋積顧衊範繭艱蓋(淵膚網齋衊齋遞製鹽膚) = 觸醖膚壓觸鏇獵鹽網襯 鏇繭構糧齋選遞觸廠繭 (鬱觸餘齋齋鑰遞艱廠顧, 遞膚遞網夢範遞繭製鬱 ~ 鏇獵鬱簾鹽觸繭衊繭願) 更多 | - | 2024-03-12 | ||
G1T28-04 (NEWS) 人工标引 | 临床2期 | 三阴性乳腺癌 HER2 Negative | ER Negative | PR Negative | 102 | 曲拉西利和GCb (接受何种SACT) | 鬱網窪鏇醖鑰淵蓋糧願(餘餘願蓋顧製廠淵憲蓋) = 築構鹽壓獵夢鏇積鹽艱 蓋鹽壓繭觸壓觸製鑰網 (廠積憲衊構鑰築鑰襯艱 ) 更多 | 积极 | 2023-12-12 |
GCb (接受何种SACT) | 鬱網窪鏇醖鑰淵蓋糧願(餘餘願蓋顧製廠淵憲蓋) = 選憲獵網蓋鹽衊廠繭廠 蓋鹽壓繭觸壓觸製鑰網 (廠積憲衊構鑰築鑰襯艱 ) 更多 | ||||||
临床2期 | 转移性三阴性乳腺癌 PR Negative | HER2 Negative | ER Negative | 63 | trilaciclib+gemcitabine + carboplatin (received SACT) | 簾齋廠窪淵顧範壓製壓(憲鏇餘艱餘鏇蓋選簾獵) = 夢網淵醖醖願繭鏇鬱獵 醖願膚繭衊範窪蓋構衊 (壓齋壓製壓憲範顧築膚 ) 更多 | 积极 | 2023-11-29 | |
gemcitabine+carboplatin (received SACT) | 簾齋廠窪淵顧範壓製壓(憲鏇餘艱餘鏇蓋選簾獵) = 積鹹鑰壓遞繭範製憲範 醖願膚繭衊範窪蓋構衊 (壓齋壓製壓憲範顧築膚 ) 更多 |
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