Recruiting
Phase 2

TAS-102

Sponsor:

Rahul Parikh

Code:

NCT03762161

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAS 102

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT03762161

Start date

Jan 3, 2019

Status verified date

Mar, 2022

Completion date

Jan, 2024

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention TAS-102

Interventions

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

Primary outcome measure

  • Clinical benefit rate (complete response+ partial response+ stable disease) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

Locations

University of Kansas Cancer Center - Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66208

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

Principal Investigator:

Rahul Parikh, MD

University of Kansas Cancer Center, Westwood Campus

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

Principal Investigator:

Rahul Parikh, MD

More Information

Sponsor

Rahul Parikh

Last update posted

Mar 10, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rahul Parikh on 2022-03-10.