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

NCT03762161 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: IIT-2018-TAS-102
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate (complete response+ partial response+ stable disease)

  Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

  Up to 6 months

Secondary Outcomes (5)

• Progression-free survival rate (PFS) among participants

  Up to 6 months

• Overall response rate (ORR) among participants

  Up to 12 months

• Overall survival rate (OS) among participants

  Up to 12 months

• Overall change in patient-reported quality of life outcomes

  Up to 26 months

• Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events

  Up to 26 months

Study Arms (1)

Intervention TAS-102

EXPERIMENTAL

Drug: TAS 102

Interventions

TAS 102 DRUG

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

Intervention TAS-102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rahul Parikh: lead
• Taiho Oncology, Inc.: collaborator

Study Sites (2)

University of Kansas Cancer Center - Clinical Research Center

Fairway, Kansas, 66208, United States

RECRUITING

University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Rahul Parikh, MD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KUCC Navigation

CONTACT

913-588-3671; kucc_navigation@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigor

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: January 3, 2019
• Primary Completion: July 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (2)