Trial Outcomes & Findings for Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer (NCT NCT04386746)
NCT ID: NCT04386746
Last Updated: 2024-12-20
Results Overview
Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology.
ACTIVE_NOT_RECRUITING
PHASE2
27 participants
3 months
2024-12-20
Participant Flow
27 subjects signed consent to be screened for eligibility. * 1 subject signed consent, but did not meet the eligibility criteria to start the study (screen failure) * 26 subjects received study treatment (1 subject withdrew consent after first dose of study therapy)
Participant milestones
| Measure |
Intravesical Gemcitabine/Docetaxel
Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Intravesical Gemcitabine/Docetaxel
n=26 Participants
Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Pre-trial pathologic stage
HGT1 with CIS
|
7 Participants
n=5 Participants
|
|
Pre-trial pathologic stage
HGT1 without CIS
|
7 Participants
n=5 Participants
|
|
Pre-trial pathologic stage
HgTa
|
9 Participants
n=5 Participants
|
|
Pre-trial pathologic stage
CIS alone
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 1 patient withdrew consent and data was not collected.
Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology.
Outcome measures
| Measure |
Intravesical Gemcitabine/Docetaxel
n=25 Participants
Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
|
|---|---|
|
3-Month Complete Response Rate
|
25 Participants
|
SECONDARY outcome
Timeframe: 12 monthsProportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsProportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsProportion of adverse events by type, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsProportion of adverse events by grade, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsNumber of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsType of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNumber of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsType of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsNumber of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsNumber of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsNumber of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsType of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsType of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsType of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNumber of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNumber of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNumber of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsType of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsType of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsType of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsNumbers of t-cell subpopulations utilizing immunohistochemical (IHC) staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsRatio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-monthsNumbers of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-monthsRatio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis.
Outcome measures
Outcome data not reported
Adverse Events
Intravesical Gemcitabine/Docetaxel
Serious adverse events
| Measure |
Intravesical Gemcitabine/Docetaxel
n=26 participants at risk
Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Infections and infestations - Other, COVID-19
|
3.8%
1/26 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Intravesical Gemcitabine/Docetaxel
n=26 participants at risk
Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Bladder infection
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Bladder spasm
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Eye disorders
Blurred vision
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
General disorders
Chills
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Confusion
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
General disorders
Malaise
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Dysuria
|
15.4%
4/26 • Number of events 4 • 3 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Eye disorders
Eye disorders - Other, Meibomian gland dysfunction
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
34.6%
9/26 • Number of events 9 • 3 years
|
|
General disorders
Fever
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
General disorders
Gait disturbance
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Eye disorders
Glaucoma
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
30.8%
8/26 • Number of events 10 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Infections and infestations - Other, COVID-19
|
15.4%
4/26 • Number of events 4 • 3 years
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Type II Diabetes
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • Number of events 5 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Other, Parkinson's disease
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
General disorders
Pain
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Investigations
Platelet count decreased
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, lower urinary tract symptoms
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, docetaxel retention
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, right breast tenderness
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Eye disorders
Retinopathy
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Nervous system disorders
Tremor
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
19.2%
5/26 • Number of events 6 • 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 2 • 3 years
|
Additional Information
Max Kates, MD
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place