Trial Outcomes & Findings for BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder (NCT NCT02657486)
NCT ID: NCT02657486
Last Updated: 2026-09-02
Results Overview
with cystoscopy and cytology. A complete response will be defined as complete disappearance of the marker lesion at the week 7 evaluation, as determined by a negative cystoscopy and cytology.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
week 7
Results posted on
2026-09-02
Participant Flow
Participant milestones
| Measure |
BGJ398
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
Baseline characteristics by cohort
| Measure |
BGJ398
n=4 Participants
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
|
|---|---|
|
Age, Continuous
|
59.8 years
n=136 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: week 7with cystoscopy and cytology. A complete response will be defined as complete disappearance of the marker lesion at the week 7 evaluation, as determined by a negative cystoscopy and cytology.
Outcome measures
| Measure |
BGJ398
n=4 Participants
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
|
|---|---|
|
Tumor Response
Complete Response
|
3 Participants
|
|
Tumor Response
No Response
|
1 Participants
|
Adverse Events
BGJ398
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BGJ398
n=4 participants at risk
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
|
|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
50.0%
2/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
25.0%
1/4 • 7 weeks
|
Other adverse events
| Measure |
BGJ398
n=4 participants at risk
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
|
|---|---|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders- Other, specify
|
25.0%
1/4 • 7 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
75.0%
3/4 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • 7 weeks
|
|
Infections and infestations
Nail infection
|
25.0%
1/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
25.0%
1/4 • 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • 7 weeks
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 7 weeks
|
|
General disorders
Pain
|
75.0%
3/4 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
1/4 • 7 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
25.0%
1/4 • 7 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
2/4 • 7 weeks
|
|
Eye disorders
Photophobia
|
25.0%
1/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • 7 weeks
|
|
Infections and infestations
Rhinitis infective
|
25.0%
1/4 • 7 weeks
|
|
Investigations
Serum amylase increased
|
50.0%
2/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
25.0%
1/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
1/4 • 7 weeks
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • 7 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
50.0%
2/4 • 7 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 7 weeks
|
|
Eye disorders
Watering eyes
|
50.0%
2/4 • 7 weeks
|
|
Investigations
Weight loss
|
25.0%
1/4 • 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • 7 weeks
|
|
Investigations
White blood cell decreased
|
25.0%
1/4 • 7 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • 7 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • 7 weeks
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • 7 weeks
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • 7 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
3/4 • 7 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • 7 weeks
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • 7 weeks
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • 7 weeks
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • 7 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • 7 weeks
|
|
Investigations
Creatinine increased
|
50.0%
2/4 • 7 weeks
|
|
Investigations
INR increased
|
25.0%
1/4 • 7 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • 7 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
3/4 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • 7 weeks
|
|
Eye disorders
Blurred vision
|
50.0%
2/4 • 7 weeks
|
|
General disorders
Chills
|
25.0%
1/4 • 7 weeks
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • 7 weeks
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • 7 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
75.0%
3/4 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
2/4 • 7 weeks
|
|
Nervous system disorders
Dysgeusia
|
100.0%
4/4 • 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • 7 weeks
|
|
General disorders
Edema limbs
|
50.0%
2/4 • 7 weeks
|
|
Eye disorders
Eye disorders - Other, specify
|
75.0%
3/4 • 7 weeks
|
|
General disorders
Fatigue
|
75.0%
3/4 • 7 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • 7 weeks
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 7 weeks
|
|
Renal and urinary disorders
Hematuria
|
50.0%
2/4 • 7 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
2/4 • 7 weeks
|
Additional Information
Dr. Jonathan Rosenberg, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4784
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place