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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-MC-S274 |
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The study was stopped early for futility reasons.
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A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression. | Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recurrence | Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence. | Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559,1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physici | Reinfeld | 23858 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34125951 | Derived | Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3. | |
| 19560257 | Derived | Bohle A, Leyh H, Frei C, Kuhn M, Tschada R, Pottek T, Wagner W, Knispel HH, von Pokrzywnitzki W, Zorlu F, Helsberg K, Lubben B, Soldatenkova V, Stoffregen C, Buttner H; S274 Study Group. Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder: a randomised, double-blind, placebo-controlled phase III multicentre study. Eur Urol. 2009 Sep;56(3):495-503. doi: 10.1016/j.eururo.2009.06.010. Epub 2009 Jun 21. |
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355 participants were enrolled and randomized (included here in disposition); however, due to study design, only 328 (N=166 Gemcitabine and N=162 Placebo) actually received study drug (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine | Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
| FG001 | Placebo | Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine | Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
| BG001 | Placebo | Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence-Free Survival (RFS) | Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression. | This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo. | Posted | Median | Full Range | Months | Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine | Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
The study was stopped early for futility reasons. In addition, due to limitations in this databank, some original outcome measures are not disclosed. Time to Recurrence and Recurrence-Free Survival in Subgroups had data that were un-estimated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Placebo | Drug | intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
|
| Recurrence-Free Survival (RFS) in Subgroups | Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression. | Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
| Tumor Recurrence Type | Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition). | Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
| Death, Other Cause |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Treatment Change |
|
| Withdrawal by Subject |
|
| Other |
|
| Not Eligible |
|
| Pathological Specimen Lost |
|
| Discontinued Prior to Instillation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Karnofsky Performance Status | Classifies patients according to their functional impairment. Rating occurs in steps of 10 score points (0=death, 10, 20,....up to 100=Normal no complaints, no evidence of disease). Lower scores indicate poorer patient condition. | Number | participants |
|
| Newly Diagnosed versus Recurrent Disease | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions | The initial TUR-BT was the first and mandatory TUR-BT during the study. An optional second TUR-BT was allowed. | Number | participants |
|
| Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage | Worst staging of the initial and optional second transurethral resection of bladder tumor. | Number | participants |
|
| Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade | Worst grading of the initial and optional second transurethral resection of bladder tumor. | Number | participants |
|
| OG001 | Placebo | Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) |
|
|
|
| Post-Hoc | Percentage of Participants Without Tumor Recurrence | Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence. | Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder. | Posted | Number | percentage of participants | Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
|
|
|
| Post-Hoc | Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months | RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG. | Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder. | Posted | Number | percentage of participants | Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
|
|
|
| Secondary | Time to Recurrence | Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence. | Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder. | Posted | Median | Full Range | months | Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
|
|
| Secondary | Recurrence-Free Survival (RFS) in Subgroups | Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression. | Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder. | Posted | Median | Full Range | months | Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
|
|
| Secondary | Tumor Recurrence Type | Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition). | Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder. | Posted | Number | participants | Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) |
|
|
|
| 17 |
| 166 |
| 38 |
| 166 |
| EG001 | Placebo | Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT) | 10 | 162 | 36 | 162 |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 8.2 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 8.2 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 8.2 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.2 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.2 | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.2 | Systematic Assessment |
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 8.2 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Cystoprostatectomy | Surgical and medical procedures | MedDRA 8.2 | Systematic Assessment |
|
| Urinary bladder excision | Surgical and medical procedures | MedDRA 8.2 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 8.2 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 8.2 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.2 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 8.2 | Systematic Assessment |
|
| Double ureter | Congenital, familial and genetic disorders | MedDRA 8.2 | Systematic Assessment |
|
| Kidney duplex | Congenital, familial and genetic disorders | MedDRA 8.2 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 8.2 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.2 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 8.2 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 8.2 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 8.2 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 8.2 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.2 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 8.2 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 8.2 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 8.2 | Systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 8.2 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 8.2 | Systematic Assessment |
|
| Post procedural nausea | Injury, poisoning and procedural complications | MedDRA 8.2 | Systematic Assessment |
|
| Post procedural vomiting | Injury, poisoning and procedural complications | MedDRA 8.2 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 8.2 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 8.2 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 8.2 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.2 | Systematic Assessment |
|
| Anticholinergic syndrome | Nervous system disorders | MedDRA 8.2 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 8.2 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 8.2 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.2 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 8.2 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 8.2 | Systematic Assessment |
|
| Bladder diverticulum | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Urethral meatus stenosis | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Urethral stricture | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Vesical tenesmus | Renal and urinary disorders | MedDRA 8.2 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 8.2 | Systematic Assessment |
|
| Urinary bladder excision | Surgical and medical procedures | MedDRA 8.2 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 8.2 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.2 | Systematic Assessment |
|
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| High Risk (G3) - 12 Months (N=13, N=14) |
|
| High Risk (G3) - 24 Months (N=13, N=14) |
|
| Newly Diagnosed Disease - 12 Months (N=94, N=98) |
|
| Newly Diagnosed Disease - 24 Months (N=94, N=98) |
|
| Recurrent Disease - 12 Months (N=30, N=26) |
|
| Recurrent Disease - 24 Months (N=30, N=26) |
|
| With BCG - 12 Months (N=13, N=21) |
|
| With BCG - 24 Months (N=13, N=21) |
|
| Without BCG - 12 Months (N=111, N=103) |
|
| Without BCG - 24 Months (N=111, N=103) |
|
| Muscle-Invasive Tumor - Any Stage ≥pT2 |
|
| pTx - Tumor Cannot be Assessed |
|