Status:
UNKNOWN
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss
Lead Sponsor:
Peking University People's Hospital
Conditions:
Safety Issues
Efficacy, Self
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control th...
Eligibility Criteria
Inclusion
- progression upon first-line chemotherapy;
- with target lesions according to RECIST 1.1;
- geno-profiling with PI3KA mutations or PTEN loss;
- ECOG PS status 0 or 1 with a life expectancy \>3 months;
- adequate renal, hepatic, and hematopoietic function;
Exclusion
- been previously exposed to other TKIs;
- had central nervous system metastasis;
- had other kinds of malignant tumors at the same time;
- had cardiac insufficiency or arrhythmia;
- had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on;
- had pleural or peritoneal effusion that needed to be handled by surgical treatment;
- had other infections or wounds;
- pregnant or breastfeeding.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04690725
Start Date
October 1 2020
End Date
June 1 2022
Last Update
December 31 2020
Active Locations (1)
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1
Peking University Shougang Hospital
Beijing, China, 100036