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
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Jiangsu
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Changzhou, Jiangsu, Kina, 213003
- Har ikke rekruttert ennå
- The First People's Hospital of Changzhou
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Ta kontakt med:
- Weiqing Zhao, Doctor
- E-post: zwq7860@163.com
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Hovedetterforsker:
- Weiqing Zhao, Doctor
-
Nanjing, Jiangsu, Kina
- Har ikke rekruttert ennå
- Nanjing Drum Tower Hospital
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Ta kontakt med:
- Huaijun Zhou, Doctor
- E-post: zhouhj2007@126.com
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Hovedetterforsker:
- Huaijun Zhou, Doctor
-
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
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Ta kontakt med:
- Xiaohua Wu, Doctor
- E-post: wu.xh@fudan.edu.cn
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Hovedetterforsker:
- Xiaohua Wu, Doctor
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Shanghai, Shanghai, Kina, 200090
- Har ikke rekruttert ennå
- Gynecology Hospital of Fudan University
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Ta kontakt med:
- Xiaojun Chen, Doctor
- E-post: cxjlhjj@163.com
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Hovedetterforsker:
- Xiaojun Chen, Doctor
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Har ikke rekruttert ennå
- Sir Run Run Shaw Hospital Medical School Zhejiang University
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Ta kontakt med:
- Xian Wang, Doctor
- E-post: yedw@srrsh.com
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Hovedetterforsker:
- Xian Wang, Doctor
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: TQ-B3525 tablet
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TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
|
Sykdomskontrollrate (DCR)
Tidsramme: opptil 48 uker
|
Andel av forsøkspersoner som oppnår fullstendig respons (CR) og delvis respons (PR) og stabil sykdom (SD).
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opptil 48 uker
|
|
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
|
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Overall survival (OS)
Tidsramme: up to 72 weeks
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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)
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TQ-B3525-II-03
Legemiddel- og utstyrsinformasjon, studiedokumenter
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