計劃書編號D0817C00098
試驗執行中
2023-03-01 - 2030-03-31
Phase III
召募中1
ICD-10C56.1
右側卵巢惡性腫瘤
ICD-10C56.2
左側卵巢惡性腫瘤
ICD-10C56.9
未明示側性卵巢惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9183.0
卵巢惡性腫瘤
ROSY-O：一項針對曾經完成Olaparib 腫瘤試驗並經由試驗主持人判定患者臨床獲益於該治療之延伸試驗
-
試驗申請者
百瑞精鼎國際股份有限公司
-
試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
-
臨床試驗規模
多國多中心
-
更新日期
2026/02/01
適應症
卵巢癌、乳癌、攝護腺癌
試驗目的
為於安全性與耐受性監測期間，經判定在臨床試驗結束時持續獲臨床效益的病患，持續提供試驗治療。
藥品名稱
膜衣錠
主成份
olaparib
劑型
116
劑量
100mg, 150mg
評估指標
通報SAE 和AESI 直到接受最後一劑試驗藥物後30天為止。
主要納入條件
The Core Protocol inclusion criteria are:
1. Provision of signed and dated, written ICF.
2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AstraZeneca (AZ) parent study using an AZ compound that has met its endpoints or has otherwise stopped.
The additional inclusion criterion for the ROSY-O sub-study is:
3. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
1. Provision of signed and dated, written ICF.
2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AstraZeneca (AZ) parent study using an AZ compound that has met its endpoints or has otherwise stopped.
The additional inclusion criterion for the ROSY-O sub-study is:
3. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
主要排除條件
The Core Protocol inclusion criteria are:
1. Provision of signed and dated, written ICF.
2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AstraZeneca (AZ) parent study using an AZ compound that has met its endpoints or has otherwise stopped.
The additional inclusion criterion for the ROSY-O sub-study is:
3. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
1. Provision of signed and dated, written ICF.
2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AstraZeneca (AZ) parent study using an AZ compound that has met its endpoints or has otherwise stopped.
The additional inclusion criterion for the ROSY-O sub-study is:
3. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
試驗計畫預計收納受試者人數
-
台灣人數
1 人
-
全球人數
193 人
