A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
NCT03762161 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2022-03-10
Summary
This study evaluates the clinical benefit of TAS-102 in participants with metastatic urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice per day on Days 1-5 and Days 8-12 of each 28 day cycle.
Conditions
Interventions
- DRUG
-
TAS 102
Participant self-administered orally at 35 milligrams per meter squared (mg/m2) twice daily Days 1-5 and 8-12 of every 28 day cycle
Sponsors & Collaborators
-
Taiho Oncology, Inc.
collaborator INDUSTRY -
Rahul Parikh
lead OTHER
Principal Investigators
-
Rahul Parikh, MD · The University of Kansas Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-03
- Primary Completion
- 2023-07-31
- Completion
- 2024-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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