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BRIEF TITLE: A Phase II Study of 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


  • Org Study ID: IIT-2018-TAS-102
  • Secondary ID:
  • NCT ID: NCT03762161
  • NCT Alias:
  • Sponsor: Rahul Parikh - Other
  • Source: University of Kansas Medical Center

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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Up to 6 months

Condition:

  • Bladder Cancer

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
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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: Kerry Hepler

Phone: 913-945-7552

Email: ctnursenav@kumc.edu

Locations

Facility Status Contact
University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas 66208
United States
Not yet recruiting kerry hepler
913-945-7552
ctnursenav@kumc.edu
University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
United States
Recruiting Clinical Trials Nurse Navigator
913-945-7552
ctnursenav@kumc.edu