Metastatic Urothelial Cancer Clinical Trial
Official title:
Phase II Study of Paclitaxel and TAK-228 in Metastatic Urothelial Carcinoma (UC) and the Impact of PI3K-mTOR Pathway Genomic Alterations
Phase II Multicentre, single arm, open label study of Paclitaxel and TAK-228 in metastatic urothelial carcinoma (UC) and the impact of PI3K-mTOR pathway genomic alterations
The PI3K/AKT/mTOR pathway has been shown to be altered in a large percentage of metastatic
urothelial carcinoma (UC) tumors. Within this pathway, the PI3 kinase alpha subunit (PIK3CA)
is frequently mutated in muscle invasive bladder cancer (MIBC) (15-20%) and PTEN is
inactivated in another 30%.
Due to TAK-228's effects on the PI3K/AKT/mTOR pathway in preclinical studies and the
frequency of pathway alterations in UC tumors, TAK-228 is a rational therapy for bladder
cancer.
This clinical investigation may also reveal how alterations in the PI3K/AKT/mTOR pathway
correlate with treatment response. In preclinical bladder cell line models and xenografts
done in our lab, synergistic effect has been seen with the combination with paclitaxel.
The primary end-point is objective response rate (ORR) with the goal of increasing the rate
from 10% to 26%. Response rates will be measured using RECIST 1.1 criteria. PFS and OS will
be measured from the start date of treatment with TAK-228 and paclitaxel. Grade 3, 4 or
serious adverse events will be collected and compared to the catalogued events in the phase
II trial in breast cancer (NCT01351350). Patient tumors will be analyzed for genetic
alterations within the PI3K/AKT/mTOR pathway to determine if alterations within this pathway
correlate with response rate, PFS, or OS.
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