- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04836663
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
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Jiangsu
-
Changzhou, Jiangsu, Kina, 213003
- Ikke rekrutterer endnu
- The First People's Hospital of Changzhou
-
Kontakt:
- Weiqing Zhao, Doctor
- E-mail: zwq7860@163.com
-
Ledende efterforsker:
- Weiqing Zhao, Doctor
-
Nanjing, Jiangsu, Kina
- Ikke rekrutterer endnu
- Nanjing Drum Tower Hospital
-
Kontakt:
- Huaijun Zhou, Doctor
- E-mail: zhouhj2007@126.com
-
Ledende efterforsker:
- Huaijun Zhou, Doctor
-
-
Shanghai
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Shanghai, Shanghai, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
-
Kontakt:
- Xiaohua Wu, Doctor
- E-mail: wu.xh@fudan.edu.cn
-
Ledende efterforsker:
- Xiaohua Wu, Doctor
-
Shanghai, Shanghai, Kina, 200090
- Ikke rekrutterer endnu
- Gynecology Hospital of Fudan University
-
Kontakt:
- Xiaojun Chen, Doctor
- E-mail: cxjlhjj@163.com
-
Ledende efterforsker:
- Xiaojun Chen, Doctor
-
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Ikke rekrutterer endnu
- Sir Run Run Shaw Hospital Medical School Zhejiang University
-
Kontakt:
- Xian Wang, Doctor
- E-mail: yedw@srrsh.com
-
Ledende efterforsker:
- Xian Wang, Doctor
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: TQ-B3525 tablet
|
TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall response rate (ORR) assessed by Independent Review Committee
Tidsramme: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
|
up to 48 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall response rate (ORR) assessed by Investigator
Tidsramme: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
Sygdomsbekæmpelseshastighed (DCR)
Tidsramme: op til 48 uger
|
Procentdel af forsøgspersoner, der opnår fuldstændig respons (CR) og delvis respons (PR) og stabil sygdom (SD).
|
op til 48 uger
|
Duration of disease remission (DOR)
Tidsramme: 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)
Tidsramme: 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
|
Overall survival (OS)
Tidsramme: 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
|
DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TQ-B3525-II-03
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med TQ-B3525 tablet
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringRecidiverende eller refraktær lymfom eller avanceret kræftKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtPerifert T-celle lymfomKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringDiffust storcellet B-celle lymfomKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Ikke rekrutterer endnu
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtEn undersøgelse af TQ-B3525 tablet til behandling af recidiverende/refraktær mantelcellelymfom (MCL)Recidiverende / Refractory Mantle Cell Lymfom (MCL)Kina
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtTilbagefaldende / Refraktær Follikulær LymfomKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.AfsluttetRecidiverende/refraktær kronisk lymfatisk leukæmi/lille lymfatisk lymfomKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringIkke-småcellet lungekræftKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtHR-positiv, HER2-negativ og PIK3CA Mutation Advanced Breast CancerKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Rekruttering