Clinical trial NCT03762161: A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
Official title: A Phase II Study of TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Taiho Oncology, Inc.
First posted: 2018-12-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical benefit rate (complete response+ partial response+ stable disease)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Progression-free survival rate (PFS) among participants
timeFrame: Up to 6 months
measure: Overall response rate (ORR) among participants
timeFrame: Up to 12 months
measure: Overall survival rate (OS) among participants
timeFrame: Up to 12 months
measure: Overall change in patient-reported quality of life outcomes
timeFrame: Up to 26 months
measure: Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events
timeFrame: Up to 26 months
Other outcomes:
Locations:
city: Fairway
country: United States
facility: University of Kansas Cancer Center - Clinical Research Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
affiliation: The University of Kansas Cancer Center
name: Rahul Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: