Viewing Study NCT01856101



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Last Modification Date: 2024-10-26 @ 11:07 AM
Study NCT ID: NCT01856101
Status: TERMINATED
Last Update Posted: 2019-04-10
First Post: 2012-12-10

Brief Title: Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Overview

Official Title: A Single Arm Multicenter Phase II Study of BEZ235 as Monotherapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma TCC After Failure of Platinum Based Chemotherapy
Status: TERMINATED
Status Verified Date: 2019-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Novartis decided to stop the marketing of BEZ235
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BEZ235
Brief Summary: The mTOR mammalian Target of Rapamycin protein is the center of the mTOR pathway that plays an important role in cell growth proliferation survival and angiogenesis through sensing and integrating energetic signals from cellular environment The mTOR protein is composed of two complex mTOR complex 1 mTOR C1 and mTOR complex 2 mTOR C2

In regards of mTOR pathway dysregulations observed in TCC development there is a rational to test BEZ23 in advanced TCC BEZ235 is a pan-class I PI3K inhibitor that in addition binds to the catalytic site of mTOR inhibiting mTOR C1 and mTOR C2
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
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
2012-004123-20 EUDRACT_NUMBER None None
CBEZ235ZBE01T OTHER CB None