A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer

  • End date
    Jan 10, 2024
  • participants needed
  • sponsor
    Rahul Parikh
Updated on 10 May 2021


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.

Condition urinary tract neoplasm, Urologic Cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, bladder disorder, Bladder Disorders, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment TAS 102
Clinical Study IdentifierNCT03762161
SponsorRahul Parikh
Last Modified on10 May 2021


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Inclusion Criteria

Ability of participant to understand this study, and participant willingness to sign a written informed consent
Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic urinary bladder (urothelial) cancer. Participants with mixed histologies are permitted as long as transitional cell carcinoma is present in the pathological specimen
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
Documented progression on or within 12 months of treatment with one previous platinum-containing regimen or ineligible to receive platinum-containing regimen. Neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-line when participants progressed within 12 months of the last dose
Documented progression on prior checkpoint inhibitor or ineligible to receive check-point inhibitor
Adequate performance status, organ, and marrow function
Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception
Men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after their last study treatment

Exclusion Criteria

Patients who have had chemotherapy or radiotherapy within 4 weeks of enrollment/registration
Current or anticipated use of other investigational agents while participating in this study
Psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or breast feeding (if applicable)
Patients with known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS 102
Patients with HIV on anti-retro-viral therapy with thymidine kinase substrates, for example, stavudine, zidovudine, telbivudine
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Undergoing active treatment for a co-existing malignancy with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy
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