Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03745911
Status:
UNKNOWN
Last Update Posted:
2018-11-19
First Post:
2018-01-09
Brief Title:
Paclitaxel and TAK-228 in Urothelial Carcinoma
Sponsor:
Associació per a la Recerca Oncologica Spain
Organization:
Associació per a la Recerca Oncologica Spain
Study Overview
Official Title:
Phase II Study of Paclitaxel and TAK-228 in Metastatic Urothelial Carcinoma UC and the Impact of PI3K-mTOR Pathway Genomic Alterations
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The PI3KAKTmTOR 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-228s effects on the PI3KAKTmTOR 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 PI3KAKTmTOR 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 11 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 PI3KAKTmTOR pathway to determine if alterations within this pathway correlate with response rate PFS or OS
Due to TAK-228s effects on the PI3KAKTmTOR 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 PI3KAKTmTOR 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 11 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 PI3KAKTmTOR pathway to determine if alterations within this pathway correlate with response rate PFS or OS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004486-27 | EUDRACT_NUMBER | None | None |