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Kinase Inhibitor
BGJ398 for Bladder Cancer
N/A
Waitlist Available
Led By Jonathan Rosenberg, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status of ≥80
Sexually active males must use a condom during intercourse while taking drug and for three months after the last dose of the study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 7
Awards & highlights
Study Summary
This trial will study the effects of BGJ398 on bladder cancer patients with tumors that have not spread outside of the bladder.
Who is the study for?
Adults with recurrent high-risk bladder cancer that hasn't invaded muscle tissue and have had prior BCG therapy. They must be able to take oral meds, perform most daily activities (Karnofsky ≥80), use effective contraception if of childbearing potential, and not have certain health conditions like severe heart disease or active infections.Check my eligibility
What is being tested?
The trial is testing BGJ398's effectiveness on bladder tumors confined to the lining. It involves patients who've failed previous treatments and have specific genetic changes in their tumors. The study requires adherence to a treatment plan including taking pills and undergoing regular tests.See study design
What are the potential side effects?
While the exact side effects are not listed here, similar medications often cause issues like dry eyes or vision problems, skin reactions, abnormal blood levels of calcium/phosphate which can affect bones and muscles, gastrointestinal disturbances affecting absorption of the drug, as well as potential interactions with other drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out normal activities with minimal symptoms.
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I will use a condom during sex while on the drug and for 3 months after.
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I can swallow and keep down pills.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
tumor response
Side effects data
From 2023 Phase 2 trial • 158 Patients • NCT0215906623%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine increased
15%
Visual field defect
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Femur fracture
8%
Cancer pain
8%
Intestinal perforation
8%
Pyrexia
8%
Aphasia
8%
Vomiting
8%
Pain in extremity
8%
Rash maculo-papular
8%
Cardiac arrest
8%
Cardiac failure
8%
Colitis
8%
Gastrointestinal haemorrhage
8%
Fatigue
8%
Blood alkaline phosphatase increased
8%
Alanine aminotransferase increased
8%
Constipation
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part II: Encorafenib + Binimetinib + Capmatinib
Part I: Encorafenib + Binimetinib (Naive)
Part I: Encorafenib + Binimetinib (Non-naive)
Part II: Encorafenib + Binimetinib + Ribociclib
Part II: Encorafenib + Binimetinib + Infigratinib
Part II: Encorafenib + Binimetinib + Buparlisib
Trial Design
1Treatment groups
Experimental Treatment
Group I: BGJ398Experimental Treatment1 Intervention
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGJ398
2009
Completed Phase 2
~480
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,616 Total Patients Enrolled
Jonathan Rosenberg, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
544 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken amiodarone in the last 90 days.I am currently taking blood thinners like warfarin.My liver and kidney functions are not normal.I am taking medications that increase my blood phosphorus or calcium levels.You have a current imbalance in calcium and phosphate levels in your body.You cannot eat certain fruits or related products for a week before starting the study.Your body's calcium and phosphate levels are not within the normal range.You have a current infection of HIV, Hepatitis B, or Hepatitis C.My doctor suspects I have an active bladder infection.I haven't taken specific cancer drugs before starting BGJ398 recently.I am not on medications that strongly affect liver enzyme CYP3A4.I have not used any herbal medications in the last 7 days.I can carry out normal activities with minimal symptoms.I have recovered from previous cancer treatments, except for hair loss and mild, stable nerve damage.My bladder cancer has returned after BCG therapy and meets specific health criteria.My cancer has spread beyond my bladder to lymph nodes or other areas.I have been diagnosed with cancer in my upper urinary tract.I have been treated with a selective FGFR inhibitor before.I have a stomach or intestine problem that affects how I absorb pills.I have or had calcifications in my body, but not in lymph nodes or blood vessels.I have a current eye condition affecting my cornea or retina.I will use a condom during sex while on the drug and for 3 months after.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 3 years.I have more than 7 tumors in my bladder.I have more than one area of carcinoma in situ not linked to a papillary tumor.I have a serious heart condition.My bone marrow is not working well.I can swallow and keep down pills.I am 18 years old or older.I haven't taken any medications that affect my heart rhythm in the last 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: BGJ398
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior experiments have incorporated BGJ398 as a component?
"Currently, 10 clinical trials are underway exploring the potential of BGJ398. Two of these studies have reached Phase 3 development and 358 medical sites across the country are participating in its evaluation. The bulk of these investigations originate from Columbus, Ohio."
Answered by AI
To what ailments is BGJ398 typically prescribed?
"BGJ398 has been tested to alleviate the symptoms of unresectable, metastatic cholangiocarcinomas in humans by targeting the fgfr2 protein. It also is a viable option for those who wish to pursue advanced directives for their care."
Answered by AI
Are there any vacancies for participants in this research?
"This trial is currently on hiatus and was last modified on February 3rd 2022. However, there are 2773 trials presently recruiting patients with bladder cancer and 10 studies for BGJ398 that have open participant slots."
Answered by AI
What is the uppermost participant limit for this experiment?
"At this time, no further participants are required for the clinical trial first posted on January 1st 2016. However, if you are seeking other studies to join, there are currently 2773 trials actively recruiting involving bladder cancer or cancer in general and 10 more related to BGJ398 that still need volunteers."
Answered by AI
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