AstraZeneca is discontinuing the CAPItello-280 Phase III trial evaluating the efficacy and safety of Truqap (capivasertib) in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer (mCRPC)..

阿斯利康正在终止CAPItello-280 III期试验，该试验评估了Truqap（capivasertib）与多西他赛和雄激素剥夺疗法（ADT）联合使用相较于多西他赛和ADT加安慰剂在转移性去势抵抗性前列腺癌（mCRPC）患者中的疗效和安全性。

This decision is based on the recommendation of the Independent Data Monitoring Committee (IDMC) following their review of data from a pre-specified interim analysis, which concluded that the Truqap combination was unlikely to meet the dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) versus the comparator arm upon trial completion.

该决定是基于独立数据监查委员会 (IDMC) 的建议，该建议是在他们审查了预先设定的中期分析数据后提出的。审查得出结论认为，与对照组相比，Truqap 联合疗法在试验完成时不太可能达到影像学无进展生存期 (rPFS) 和总生存期 (OS) 的双重主要终点。

The safety profile for Truqap was consistent with previous trials..

Truqap 的安全性与之前的试验一致。

The Company will work with investigators to ensure the necessary follow up with patients. Data from the trial will inform ongoing research.

公司将与调查人员合作，确保对患者进行必要的随访。试验数据将为正在进行的研究提供信息。

CAPItello-280 is a Phase III, double-blind, randomised trial

CAPItello-280 是一项 III 期、双盲、随机试验

evaluating the efficacy and safety of

评估有效性和安全性

Truqap

楚鲁普

in combination with docetaxel and ADT compared to docetaxel and ADT in combination with placebo in patients with mCRPC.

与多西他赛和ADT联合使用相比，多西他赛和ADT联合安慰剂在mCRPC患者中的应用。

The global trial enrolled 1,033 adult patients with histologically confirmed prostate adenocarcinoma with evidence of mCRPC with progression of disease despite ADT. The dual primary endpoints of the CAPItello-280 trial are rPFS as assessed by investigator and OS in the overall trial population. Key secondary endpoints include OS and rPFS as assessed by investigator in patients with mCRPC and PTEN-deficient tumours, OS and rPFS as assessed by investigator in patients with mCRPC and PTEN-proficient tumours, time to pain progression (TTPP) in the overall trial population and time to first symptomatic skeletal-related event (SSRE) in the overall trial population..

全球试验招募了1033名经组织学确认患有前列腺腺癌的成年患者，这些患者尽管接受雄激素剥夺治疗（ADT），仍有转移性去势抵抗性前列腺癌（mCRPC）的疾病进展证据。CAPItello-280试验的双重主要终点是由研究者评估的无进展生存期（rPFS）和总体试验人群的总生存期（OS）。关键次要终点包括：研究者评估的mCRPC和PTEN缺陷肿瘤患者的OS和rPFS，研究者评估的mCRPC和PTEN正常肿瘤患者的OS和rPFS，总体试验人群的疼痛进展时间（TTPP），以及总体试验人群首次出现症状性骨骼相关事件（SSRE）的时间。

Condition:

条件：

Prostate Cancer

前列腺癌

Type:

类型：

drug

药物