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Brief Title: TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer

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

INTRODUCTION

  • Org Study ID: IIT-2018-TAS-102
  • Secondary ID: N/A
  • NTC ID: NCT03762161
  • Sponsor: Rahul Parikh

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.

  • Overall Status
    Recruiting
  • Start Date
    January 3, 2019
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Clinical benefit rate (complete response+ partial response+ stable disease)

Primary Outcome 1 - Timeframe: Up to 6 months

CONDITION

  • Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Rahul Parikh, MD

Role: Principal Investigator

Affiliation: The University of Kansas Cancer Center

Overall Contact

Name: Rahul Parikh, MD

Phone: 913-588-3671

Email: kucc_navigation@kumc.edu

LOCATION

Facility Status Contact
Facility: University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas 66208
United States
Status: Recruiting Contact: Contact
KUCC Navigation
913-588-3671
kucc_navigation@kumc.edu
Facility: University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
United States
Status: Recruiting Contact: Principal Investigator
Rahul Parikh, MD
913-588-3671
kucc_navigation@kumc.edu