Bladder CancerPhase 2NCT03762161
A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
A Phase 2 study testing TAS 102 in people with Bladder Cancer, run by Rahul Parikh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- TAS 102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2019to Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas, 66208
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
Rahul Parikh, MD
- Recruiting
University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
Rahul Parikh, MD
About this study
Official title: A Phase II Study of TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
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
- Being tested
- TAS 102
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS 102Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention TAS-102 | Experimental | Not described Receives: Drug: TAS 102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (complete response+ partial response+ stable disease)
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Measured: Up to 6 months
Secondary outcomes (5)
Progression-free survival rate (PFS) among participants
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Measured: Up to 6 months
Overall response rate (ORR) among participants
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Measured: Up to 12 months
Overall survival rate (OS) among participants
Evaluated per Medical Record
Measured: Up to 12 months
Overall change in patient-reported quality of life outcomes
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".
Measured: Up to 26 months
Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events
Evaluated per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start3 Jan 2019
- Primary completionJul 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahul Parikh
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Oncology, Inc.
- Responsible party
- Sponsor-investigator, Rahul Parikh, University of Kansas Medical Center
- Investigators
- Rahul Parikh, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762161
- Sponsor's protocol ID
- IIT-2018-TAS-102
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
- ClinicalTrials.gov ID
- NCT03762161
- Acronym / sponsor ID
- IIT-2018-TAS-102
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Rahul ParikhUniversity, hospital or other
- Collaborators
- Taiho Oncology, Inc.
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention TAS-102 | Experimental | Drug: TAS 102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS 102Participant self-administered orally at 35 milligrams per meter squared (mg/m2) twice daily Days 1-5 and 8-12 of every 28 day cycle | Drug | Intervention TAS-102 |
Primary outcome
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
5 secondary outcomes
Progression-free survival rate (PFS) among participants
Time frame: Up to 6 months
Overall response rate (ORR) among participants
Time frame: Up to 12 months
Overall survival rate (OS) among participants
Time frame: Up to 12 months
Overall change in patient-reported quality of life outcomes
Time frame: Up to 26 months
Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events
Time frame: Up to 26 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Bladder Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Parikh, MD principal investigator
The University of Kansas Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS 102 in people with Bladder Cancer, run by Rahul Parikh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KUCC Navigation (913-588-3671, kucc_navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (complete response+ partial response+ stable disease) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.