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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- Nog niet aan het werven
- The First People's Hospital of Changzhou
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Contact:
- Weiqing Zhao, Doctor
- E-mail: zwq7860@163.com
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Hoofdonderzoeker:
- Weiqing Zhao, Doctor
-
Nanjing, Jiangsu, China
- Nog niet aan het werven
- Nanjing Drum Tower Hospital
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Contact:
- Huaijun Zhou, Doctor
- E-mail: zhouhj2007@126.com
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Hoofdonderzoeker:
- Huaijun Zhou, Doctor
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Werving
- Fudan University Shanghai Cancer Center
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Contact:
- Xiaohua Wu, Doctor
- E-mail: wu.xh@fudan.edu.cn
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Hoofdonderzoeker:
- Xiaohua Wu, Doctor
-
Shanghai, Shanghai, China, 200090
- Nog niet aan het werven
- Gynecology Hospital of Fudan University
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Contact:
- Xiaojun Chen, Doctor
- E-mail: cxjlhjj@163.com
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Hoofdonderzoeker:
- Xiaojun Chen, Doctor
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Nog niet aan het werven
- Sir Run Run Shaw Hospital Medical School Zhejiang University
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Contact:
- Xian Wang, Doctor
- E-mail: yedw@srrsh.com
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Hoofdonderzoeker:
- Xian Wang, Doctor
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: TQ-B3525 tablet
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TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall response rate (ORR) assessed by Independent Review Committee
Tijdsspanne: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
|
up to 48 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall response rate (ORR) assessed by Investigator
Tijdsspanne: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
|
Ziektebestrijdingspercentage (DCR)
Tijdsspanne: tot 48 weken
|
Percentage proefpersonen dat volledige respons (CR) en partiële respons (PR) en stabiele ziekte (SD) bereikt.
|
tot 48 weken
|
|
Duration of disease remission (DOR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TQ-B3525-II-03
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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