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Anti-metabolites
Lonsurf for Bladder Cancer
Phase 2
Waitlist Available
Led By Rahul Parikh, MD
Research Sponsored by Rahul Parikh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug, TAS-102, to see if it helps people with urothelial carcinoma who haven't responded to other treatments.
Who is the study for?
This trial is for adults with advanced bladder cancer that has spread and doesn't respond to platinum-based chemotherapy or checkpoint inhibitors. They must have measurable disease, be in good health otherwise, and agree to use effective contraception. It's not for pregnant women, those with brain metastases, HIV patients on certain therapies, recent chemo or radiotherapy recipients, people using other investigational drugs, or those with serious illnesses.
What is being tested?
The study tests TAS-102 effectiveness in treating metastatic bladder cancer resistant to standard treatments. Participants will take TAS-102 orally twice daily on specific days over a 28-day cycle. The goal is to see if this drug can help where others haven't.
What are the potential side effects?
While the trial information does not specify side effects of TAS-102 for this condition, common ones from similar medications include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 26 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate (complete response+ partial response+ stable disease)
Secondary study objectives
Overall change in patient-reported quality of life outcomes
Overall response rate (ORR) among participants
Overall survival rate (OS) among participants
+2 moreSide effects data
From 2024 Phase 2 trial • 23 Patients • NCT0368648861%
Fatigue
57%
Diarrhea
57%
Nausea
52%
Vomiting
48%
Headache
39%
Hypertension
26%
Dizziness
26%
Anorexia
26%
Neutrophil count decreased
26%
Dyspnea
26%
Constipation
22%
General disorders and administration site conditions - Other
22%
Anemia
22%
Gastrointestinal disorders -Other
17%
Cough
17%
White blood cell decreased
17%
Abdominal pain
17%
Chills
17%
Pain
13%
Epistaxis
13%
Injury, poisoning and procedural complications - Other
13%
Flank pain
13%
Death NOS
13%
Lymphocyte count decreased
13%
Toothache
13%
Edema limbs
13%
Non-cardiac chest pain
9%
Hyponatremia
9%
Weight loss
9%
Hoarseness
9%
Nervous system disorders - Other
9%
Ascites
9%
Flu like symptoms
9%
Weight gain
9%
Dysphagia
9%
Platelet count decreased
4%
Electrocardiogram QT corrected interval prolonged
4%
Aspartate aminotransferase increased
4%
Hyperglycemia
4%
Myalgia
4%
Renal colic
4%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
4%
Reproductive system and breast disorders - Other,
4%
Atrial fibrillation
4%
Urine discoloration
4%
Alopecia
4%
Hypotension
4%
Shingles
4%
Fall
4%
Anxiety
4%
Blurred vision
4%
Bronchial infection
4%
Pericardial effusion
4%
Palpitations
4%
Stroke
4%
Blood bilirubin increased
4%
Lipase increased
4%
Thromboembolic event
4%
Skin infection
4%
Pain in extremity
4%
Peripheral sensory neuropathy
4%
Restlessness
4%
Arthralgia
4%
Muscle weakness lower limb
4%
Hematuria
4%
Dry mouth
4%
Hemorrhoids
4%
Upper gastrointestinal hemorrhage
4%
Multi-organ failure
4%
Pleural effusion
4%
Productive cough
4%
Respiratory, thoracic and mediastinal disorders - Other
4%
Sudden death NOS
4%
Infections and infestations- Other
4%
Colonic hemorrhage
4%
Stomach pain
4%
Dental caries
4%
Dyspepsia
4%
Oral hemorrhage
4%
Alanine aminotransferase increased
4%
Fever
4%
Hypokalemia
4%
Infections and infestations - Other
4%
Psychiatric disorders - Other
4%
Proteinuria
4%
Urinary frequency
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Ear and labyrinth disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAS 102 and Ramucirumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention TAS-102Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS 102
2017
Completed Phase 3
~500
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Industry Sponsor
78 Previous Clinical Trials
13,068 Total Patients Enrolled
Rahul ParikhLead Sponsor
Rahul Parikh, MD5.04 ReviewsPrincipal Investigator - The University of Kansas Cancer Center
University of Kansas Medical Center
1 Previous Clinical Trials
4 Total Patients Enrolled
5Patient Review
Dr. Parikh is an excellent doctor who saved my life. He is kind and intelligent, with a willingness to take suggestions and get second opinions. His staff are just as wonderful as he is. I feel so lucky to have found him.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to your brain.You have had allergic reactions to drugs similar to TAS 102.You must have a visible and measurable tumor that can be accurately measured.You have been diagnosed with advanced urinary bladder cancer, and the type of cancer cells in your biopsy is transitional cell carcinoma.You have a serious illness that is not under control, such as an ongoing infection or heart problems. If you are currently being treated for another type of cancer, you may not be eligible for the study.You have experienced worsening of your condition while taking a previous checkpoint inhibitor, or you are not allowed to take a checkpoint inhibitor.You have HIV and are taking specific medications for it.You have experienced disease progression within 12 months of receiving a specific type of chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention TAS-102
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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