A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
A Open-label, Multicenter Phase II Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Jiangsu
-
Changzhou、Jiangsu、中国、213003
- まだ募集していません
- The First People's Hospital of Changzhou
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コンタクト：
- Weiqing Zhao, Doctor
- メール：zwq7860@163.com
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主任研究者：
- Weiqing Zhao, Doctor
-
Nanjing、Jiangsu、中国
- まだ募集していません
- Nanjing Drum Tower Hospital
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コンタクト：
- Huaijun Zhou, Doctor
- メール：zhouhj2007@126.com
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主任研究者：
- Huaijun Zhou, Doctor
-
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Shanghai
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Shanghai、Shanghai、中国、200032
- 募集
- Fudan University Shanghai Cancer Center
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コンタクト：
- Xiaohua Wu, Doctor
- メール：wu.xh@fudan.edu.cn
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主任研究者：
- Xiaohua Wu, Doctor
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Shanghai、Shanghai、中国、200090
- まだ募集していません
- Gynecology Hospital of Fudan University
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コンタクト：
- Xiaojun Chen, Doctor
- メール：cxjlhjj@163.com
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主任研究者：
- Xiaojun Chen, Doctor
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Zhejiang
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Hangzhou、Zhejiang、中国、310016
- まだ募集していません
- Sir Run Run Shaw Hospital Medical School Zhejiang University
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コンタクト：
- Xian Wang, Doctor
- メール：yedw@srrsh.com
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主任研究者：
- Xian Wang, Doctor
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
1. Pathologically confirmed malignant gynecological neoplasm. 2. Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion.
4.Failed with standard treatment or has no effective treatment. 5. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months.
6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and signed an informed consent form.
Exclusion Criteria:
1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
3. Insufficient hematopoietic function of bone marrow. 4. Dysfunction of liver and kidney. 5. Bleeding risk. 6. Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days. 10. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
11. Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction.
12. The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid <10 mg, except metacortandracin or other therapeutic hormones and so on).
13. Has active infections. 14. Has human immunodeficiency virus (HIV). 15. Pregnant or lactating women. 16. Has psychotropic substances abuse or a mental disorder. 17. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
18. Patient's compliance is inadequate.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TQ-B3525 tablet
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TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall response rate (ORR) assessed by Independent Review Committee
時間枠：up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
|
up to 48 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall response rate (ORR) assessed by Investigator
時間枠：up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
|
疾病制御率（DCR）
時間枠：48週まで
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完全奏効（CR）、部分奏効（PR）、病態安定（SD）を達成した被験者の割合。
|
48週まで
|
|
Duration of disease remission (DOR)
時間枠：up to 48 weeks
|
The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).
|
up to 48 weeks
|
|
Progression-free survival (PFS)
時間枠：up to 48 weeks
|
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
|
up to 48 weeks
|
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Overall survival (OS)
時間枠：up to 72 weeks
|
OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
|
up to 72 weeks
|
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DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
時間枠：up to 48 weeks
|
The percentage of subjects achieving CR or PR was recorded for the first time to 6 months after the first time of objective tumor progression or death due to any cause (whichever occurred first) was recorded.
|
up to 48 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。