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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762161
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : March 10, 2022
Sponsor:
Collaborator:
Taiho Oncology, Inc.
Information provided by (Responsible Party):
Rahul Parikh, University of Kansas Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: TAS 102 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention TAS-102 Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical benefit rate (complete response+ partial response+ stable disease) [ Time Frame: Up to 6 months ]
    Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1


Secondary Outcome Measures :
  1. Progression-free survival rate (PFS) among participants [ Time Frame: Up to 6 months ]
    Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

  2. Overall response rate (ORR) among participants [ Time Frame: Up to 12 months ]
    Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

  3. Overall survival rate (OS) among participants [ Time Frame: Up to 12 months ]
    Evaluated per Medical Record

  4. Overall change in patient-reported quality of life outcomes [ Time Frame: Up to 26 months ]

    Evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores

    • FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL.

    • FACT-Bl includes five sub-scales:

      • Physical Well-being (PWB), score range of 0-28
      • Social/Family Well-being (SWB), score range of 0-28
      • Emotional Well-being (EWB), score range of 0-24
      • Functional Well-being (FWB), score range of 0-28
      • Bladder Cancer Subscale (BlCS), score range of 0-48
    • Note: Negatively stated items are reversed by subtracting the response from "4".

  5. Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events [ Time Frame: Up to 26 months ]
    Evaluated per Common Terminology Criteria for Adverse Events (CTCAE) v5.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762161


Contacts
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Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu

Locations
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United States, Kansas
University of Kansas Cancer Center - Clinical Research Center Recruiting
Fairway, Kansas, United States, 66208
Contact: KUCC Navigation    913-588-3671    kucc_navigation@kumc.edu   
Principal Investigator: Rahul Parikh, MD         
University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: KUCC Navigation    913-588-3671    kucc_navigation@kumc.edu   
Principal Investigator: Rahul Parikh, MD         
Sponsors and Collaborators
Rahul Parikh
Taiho Oncology, Inc.
Investigators
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Principal Investigator: Rahul Parikh, MD The University of Kansas Cancer Center
More Information
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Responsible Party: Rahul Parikh, Principal Investigor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03762161    
Other Study ID Numbers: IIT-2018-TAS-102
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases