Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in pts w/ Muscle Invasive Bladder Cancer - BISCAY

Study identifier:D2615C00001

ClinicalTrials.gov identifier:NCT02546661

EudraCT identifier:2015-002228-25

CTIS identifier:N/A

Recruitment Complete

Official Title

An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in patients with Muscle Invasive Bladder Cancer (MIBC) who have progressed on prior treatment (BISCAY).

Medical condition

Muscle invasive bladder cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD4547, MEDI4736, Olaparib, AZD1775, Vistusertib, AZD9150, Selumetinib

Sex

All

Actual Enrollment

117

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Dec 2016
Primary Completion Date: 18 Mar 2020
Estimated Study Completion Date: 18 Oct 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria