Study Title: ATLANTIS: An adaptive multi-arm phase II trial of maintenance targeted therapy after chemotherapy in metastatic urothelial cancer
Study Design: ATLANTIS is a randomised phase II biomarker directed umbrella screening trial of maintenance therapy in biomarker defined subgroups of patients with advanced urothelial cancer. The primary endpoint is progression-free survival.
Objectives: The trial will investigate whether maintenance targeted therapy after chemotherapy, with treatment selection based on biomarker expression, delays time to progression and overall survival for patients with MUC.
Endpoints:
Primary: To compare progression-free survival (PFS) of trial drug and placebo/observation. Different drugs will be tested in different biomarker defined subgroups in an adaptive design. PFS has been chosen as the primary end-point as it is largely objective (the majority of urothelial cancer patients will display progression in accordance with RECIST1.1 criteria) and clinically meaningful - progression after first line therapy represents the transition to the lethal stage of the disease and often the requirement for further cytotoxic therapy.
Secondary: Overall survival, response rate, maximum percentage decrease in measurable disease, safety and tolerability.
Exploratory: Progression free survival in subgroups defined by biomarkers other than those used for treatment allocation.
Translational: Archival tissue, plasma, circulating tumor DNA and urine will be stored and used for future research.
Trial Status: In Follow-Up
Chief Investigator: Prof Rob Jones/Prof Thomas Powles
Sponsor: NHS Greater Glasgow & Clyde and the University of Glasgow
Date Opened: 23 February 2017
Planned Closure Date: September 2018
Target Recruitment: 140
Open to New Sites: Yes
Contact Details:
Eileen Soulis (Project Manager)
Cancer Research UK Clinical Trials Unit, Glasgow
Beatson West of Scotland Cancer Centre
1053 Great Western Road, Glasgow, G12 0YN
Tel: 00 44 (0) 141 301 7184
Fax: 00 44 (0) 141 301 7946
E-mail: [email protected]
For queries concerning Pharmacovigilance, or the documents to refer to for the clinical management of trial patients or those that are acting as the Reference Safety Information please contact:
The Pharmacovigilance Team email: [email protected] or
Telephone: 0141 211 0352/0203/3567/3968 or 0141 232 2068
Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) being used for the study: 4.03
Click here to download the CTCAE
