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Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)

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ClinicalTrials.gov Identifier: NCT00461591
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : August 15, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bladder Cancer
Interventions Drug: Apaziquone
Drug: Placebo
Procedure: TURBT
Enrollment 802
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Period Title: Overall Study
Started 406 396
Completed 317 311
Not Completed 89 85
Arm/Group Title Apaziquone Placebo Total
Hide Arm/Group Description Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT Total of all reporting groups
Overall Number of Baseline Participants 406 396 802
Hide Baseline Analysis Population Description
Safety/ITT Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 406 participants 396 participants 802 participants
67.5  (10.92) 68.2  (10.72) 67.8  (10.82)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 406 participants 396 participants 802 participants
<65
159
  39.2%
146
  36.9%
305
  38.0%
65-75
140
  34.5%
139
  35.1%
279
  34.8%
>75
107
  26.4%
111
  28.0%
218
  27.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 396 participants 802 participants
Female
108
  26.6%
102
  25.8%
210
  26.2%
Male
298
  73.4%
294
  74.2%
592
  73.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 396 participants 802 participants
Hispanic or Latino
13
   3.2%
17
   4.3%
30
   3.7%
Not Hispanic or Latino
393
  96.8%
379
  95.7%
772
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 396 participants 802 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.2%
3
   0.8%
4
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
   2.7%
9
   2.3%
20
   2.5%
White
392
  96.6%
383
  96.7%
775
  96.6%
More than one race
2
   0.5%
1
   0.3%
3
   0.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 406 participants 396 participants 802 participants
United States 381 375 756
Poland 25 21 46
1.Primary Outcome
Title Recurrence Rate at 2 Years
Hide Description The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Measure Type: Count of Participants
Unit of Measure: Participants
Recurrence
112
  38.0%
121
  44.6%
Non-Recurrence
183
  62.0%
150
  55.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apaziquone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1068
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.54 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Recurrence
Hide Description The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Mean (Standard Error)
Unit of Measure: months
18.3  (0.47) 16.7  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apaziquone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0412
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.59 to 0.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression Rate at 2 Years
Hide Description The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Measure Type: Count of Participants
Unit of Measure: Participants
Progression
30
  10.2%
39
  14.4%
Non-Progression
265
  89.8%
232
  85.6%
4.Secondary Outcome
Title Time to Progression
Hide Description The number of months from randomization to progression to either a higher stage or grade of the patient’s bladder tumor.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Mean (Standard Error)
Unit of Measure: months
22.9  (0.26) 22.0  (0.34)
5.Secondary Outcome
Title Number of Recurrences Per Patient
Hide Description The number of histologically confirmed recurrences during the course of the study.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Mean (Standard Deviation)
Unit of Measure: times
0.6  (1.03) 0.9  (1.21)
6.Secondary Outcome
Title Disease Free Interval
Hide Description The number of months from randomization to histologically confirmed progression of the patient’s bladder tumor or death from any cause
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Mean (Standard Error)
Unit of Measure: months
22.9  (0.26) 22.0  (0.34)
7.Secondary Outcome
Title Disease Free Survival
Hide Description The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor or death from any cause
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Mean (Standard Error)
Unit of Measure: months
18.0  (0.48) 16.4  (0.55)
8.Secondary Outcome
Title Overall Survival
Hide Description The number of months from randomization to death from any cause.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description:
Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Number of Participants Analyzed 295 271
Mean (Standard Error)
Unit of Measure: months
20.3  (0.13) 23.7  (0.14)
Time Frame Treatment-emergent Adverse Events (ie, AEs that occurred or worsened following the TURBT procedure) were recorded from the time of randomization to Month 6; after Month 6 until Month 24 (end of study), only genitourinary AEs and Serious AEs (SAEs) were recorded.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apaziquone Placebo
Hide Arm/Group Description Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
All-Cause Mortality
Apaziquone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/406 (2.71%)   13/396 (3.28%) 
Show Serious Adverse Events Hide Serious Adverse Events
Apaziquone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   93/406 (22.91%)   98/396 (24.75%) 
Blood and lymphatic system disorders     
Iron deficiency anemia * 1  1/406 (0.25%)  1/396 (0.25%) 
Anemia of chronic disease * 1  1/406 (0.25%)  0/396 (0.00%) 
Anemia * 1  0/406 (0.00%)  1/396 (0.25%) 
Cardiac disorders     
Atrial Fibrillation * 1  6/406 (1.48%)  0/396 (0.00%) 
Cardiac Failure Congestive * 1  5/406 (1.23%)  6/396 (1.52%) 
Coronary Artery Disease * 1  3/406 (0.74%)  6/396 (1.52%) 
Myocardial Infarction * 1  3/406 (0.74%)  3/396 (0.76%) 
Acute Myocardial Infarction * 1  2/406 (0.49%)  1/396 (0.25%) 
Acute Coronary Syndrome * 1  2/406 (0.49%)  0/396 (0.00%) 
Atrioventricular block complete * 1  1/406 (0.25%)  1/396 (0.25%) 
Bradycardia * 1  1/406 (0.25%)  0/396 (0.00%) 
Cardiac arrest * 1  1/406 (0.25%)  0/396 (0.00%) 
Cardiac tamponade * 1  1/406 (0.25%)  0/396 (0.00%) 
Coronary artery stenosis * 1  1/406 (0.25%)  0/396 (0.00%) 
Sinus bradycardia * 1  1/406 (0.25%)  0/396 (0.00%) 
Ventricular fibrillation * 1  1/406 (0.25%)  0/396 (0.00%) 
Arteriosclerosis coronary artery * 1  0/406 (0.00%)  1/396 (0.25%) 
Atrial tachycardia * 1  0/406 (0.00%)  1/396 (0.25%) 
Cardiac perforation * 1  0/406 (0.00%)  1/396 (0.25%) 
Cardiopulmonary failure * 1  0/406 (0.00%)  1/396 (0.25%) 
Palpitations * 1  0/406 (0.00%)  1/396 (0.25%) 
Ventricular tachycardia * 1  0/406 (0.00%)  1/396 (0.25%) 
Eye disorders     
Cataract * 1  0/406 (0.00%)  1/396 (0.25%) 
Gastrointestinal disorders     
Small Intestinal Obstruction * 1  1/406 (0.25%)  2/396 (0.51%) 
Pancreatitis acute * 1  0/406 (0.00%)  2/396 (0.51%) 
Abdominal pain * 1  1/406 (0.25%)  0/396 (0.00%) 
Diarrhea * 1  1/406 (0.25%)  0/396 (0.00%) 
Duodenal ulcer * 1  1/406 (0.25%)  0/396 (0.00%) 
Ileus * 1  1/406 (0.25%)  0/396 (0.00%) 
Intestinal perforation * 1  1/406 (0.25%)  0/396 (0.00%) 
Intra-abdominal hemorrhage * 1  1/406 (0.25%)  0/396 (0.00%) 
Large intestine polyp * 1  1/406 (0.25%)  0/396 (0.00%) 
Nausea * 1  1/406 (0.25%)  0/396 (0.00%) 
Upper gastrointestinal hemorrhage * 1  1/406 (0.25%)  0/396 (0.00%) 
Vomiting * 1  1/406 (0.25%)  0/396 (0.00%) 
Colitis ischemic * 1  0/406 (0.00%)  1/396 (0.25%) 
Colitis ulcerative * 1  0/406 (0.00%)  1/396 (0.25%) 
Duodenal ulcer hemorrhage * 1  0/406 (0.00%)  1/396 (0.25%) 
Gallstone ileus * 1  0/406 (0.00%)  1/396 (0.25%) 
Gastrointestinal hemorrhage * 1  0/406 (0.00%)  1/396 (0.25%) 
Inguinal hernia, obstructive * 1  0/406 (0.00%)  1/396 (0.25%) 
Pancreatic mass * 1  0/406 (0.00%)  1/396 (0.25%) 
Rectal prolapse * 1  0/406 (0.00%)  1/396 (0.25%) 
Retroperitoneal hemorrhage * 1  0/406 (0.00%)  1/396 (0.25%) 
General disorders     
Chest Pain * 1  5/406 (1.23%)  4/396 (1.01%) 
Death * 1  2/406 (0.49%)  0/396 (0.00%) 
Asthenia * 1  1/406 (0.25%)  0/396 (0.00%) 
Ischemic ulcer * 1  1/406 (0.25%)  0/396 (0.00%) 
Generalised oedema * 1  0/406 (0.00%)  1/396 (0.25%) 
Hepatobiliary disorders     
Cholecystitis Acute * 1  2/406 (0.49%)  0/396 (0.00%) 
Cholecystitis * 1  1/406 (0.25%)  0/396 (0.00%) 
Immune system disorders     
Anaphylactic reaction * 1  1/406 (0.25%)  0/396 (0.00%) 
Infections and infestations     
Pneumonia * 1  5/406 (1.23%)  7/396 (1.77%) 
Cellulitis * 1  5/406 (1.23%)  3/396 (0.76%) 
Urinary Tract Infection * 1  2/406 (0.49%)  5/396 (1.26%) 
Sepsis * 1  2/406 (0.49%)  3/396 (0.76%) 
Abdominal wall abscess * 1  1/406 (0.25%)  0/396 (0.00%) 
Appendicitis * 1  1/406 (0.25%)  0/396 (0.00%) 
Bronchitis * 1  1/406 (0.25%)  0/396 (0.00%) 
Gastroenteritis viral * 1  1/406 (0.25%)  0/396 (0.00%) 
Influenza * 1  1/406 (0.25%)  0/396 (0.00%) 
Appendicitis perforated * 1  0/406 (0.00%)  1/396 (0.25%) 
Brain abscess * 1  0/406 (0.00%)  1/396 (0.25%) 
Cystitis * 1  0/406 (0.00%)  1/396 (0.25%) 
Herpes zoster * 1  0/406 (0.00%)  1/396 (0.25%) 
Osteomyelitis * 1  0/406 (0.00%)  1/396 (0.25%) 
Peritonitis * 1  0/406 (0.00%)  1/396 (0.25%) 
Urinary tract infection enterococcal * 1  0/406 (0.00%)  1/396 (0.25%) 
Injury, poisoning and procedural complications     
Subdural hematoma * 1  1/406 (0.25%)  1/396 (0.25%) 
Toxicity to various agents * 1  1/406 (0.25%)  1/396 (0.25%) 
Hip fracture * 1  0/406 (0.00%)  2/396 (0.51%) 
Ankle fracture * 1  1/406 (0.25%)  0/396 (0.00%) 
Incisional hernia * 1  1/406 (0.25%)  0/396 (0.00%) 
Post procedural hematuria * 1  1/406 (0.25%)  0/396 (0.00%) 
Procedural nausea * 1  1/406 (0.25%)  0/396 (0.00%) 
Procedural pain * 1  1/406 (0.25%)  0/396 (0.00%) 
Spinal compression fracture * 1  1/406 (0.25%)  0/396 (0.00%) 
Cervical vertebral fracture * 1  0/406 (0.00%)  1/396 (0.25%) 
Fall * 1  0/406 (0.00%)  1/396 (0.25%) 
Femur fracture * 1  0/406 (0.00%)  1/396 (0.25%) 
Multiple injuries * 1  0/406 (0.00%)  1/396 (0.25%) 
Pneumothorax traumatic * 1  0/406 (0.00%)  1/396 (0.25%) 
Post procedural hemorrhage * 1  0/406 (0.00%)  1/396 (0.25%) 
Seroma * 1  0/406 (0.00%)  1/396 (0.25%) 
Investigations     
Anticoagulation drug level above therapeutic * 1  0/406 (0.00%)  1/396 (0.25%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/406 (0.49%)  1/396 (0.25%) 
Electrolyte imbalance * 1  1/406 (0.25%)  0/396 (0.00%) 
Type 2 diabetes mellitus * 1  1/406 (0.25%)  0/396 (0.00%) 
Cachexia * 1  0/406 (0.00%)  1/396 (0.25%) 
Diabetes mellitus * 1  0/406 (0.00%)  1/396 (0.25%) 
Diabetes mellitus inadequate control * 1  0/406 (0.00%)  1/396 (0.25%) 
Hyponatremia * 1  0/406 (0.00%)  1/396 (0.25%) 
Metabolic acidosis * 1  0/406 (0.00%)  1/396 (0.25%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  2/406 (0.49%)  1/396 (0.25%) 
Intervertebral Disc Degeneration * 1  2/406 (0.49%)  0/396 (0.00%) 
Lumbar spinal stenosis * 1  1/406 (0.25%)  1/396 (0.25%) 
Osteoarthritis * 1  1/406 (0.25%)  1/396 (0.25%) 
Muscular weakness * 1  1/406 (0.25%)  0/396 (0.00%) 
Spinal osteoarthritis * 1  1/406 (0.25%)  0/396 (0.00%) 
Flank pain * 1  0/406 (0.00%)  1/396 (0.25%) 
Intervertebral disc protrusion * 1  0/406 (0.00%)  1/396 (0.25%) 
Osteonecrosis * 1  0/406 (0.00%)  1/396 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastrointestinal stromal tumor * 1  1/406 (0.25%)  1/396 (0.25%) 
Renal cell carcinoma * 1  1/406 (0.25%)  1/396 (0.25%) 
Adenocarcinoma of colon * 1  1/406 (0.25%)  0/396 (0.00%) 
Bladder cancer recurrent * 1  1/406 (0.25%)  0/396 (0.00%) 
Colon cancer * 1  1/406 (0.25%)  0/396 (0.00%) 
Lung adenocarcinoma stage I * 1  1/406 (0.25%)  0/396 (0.00%) 
Lung neoplasm malignant * 1  1/406 (0.25%)  0/396 (0.00%) 
Ureteric cancer * 1  1/406 (0.25%)  0/396 (0.00%) 
Brain cancer metastatic * 1  0/406 (0.00%)  1/396 (0.25%) 
Cholesteatoma * 1  0/406 (0.00%)  1/396 (0.25%) 
Lung neoplasm * 1  0/406 (0.00%)  1/396 (0.25%) 
Metastases to lung * 1  0/406 (0.00%)  1/396 (0.25%) 
Metastases to spine * 1  0/406 (0.00%)  1/396 (0.25%) 
Metastatic bronchial carcinoma * 1  0/406 (0.00%)  1/396 (0.25%) 
Neoplasm malignant * 1  0/406 (0.00%)  1/396 (0.25%) 
Non-small cell lung cancer metastatic * 1  0/406 (0.00%)  1/396 (0.25%) 
Prostate cancer * 1  0/406 (0.00%)  1/396 (0.25%) 
Prostate cancer metastatic * 1  0/406 (0.00%)  1/396 (0.25%) 
Urinary tract neoplasm * 1  0/406 (0.00%)  1/396 (0.25%) 
Nervous system disorders     
Syncope * 1  3/406 (0.74%)  2/396 (0.51%) 
Transient Ischemic Attack * 1  2/406 (0.49%)  1/396 (0.25%) 
Cerebrovascular Accident * 1  1/406 (0.25%)  2/396 (0.51%) 
Carotid artery disease * 1  1/406 (0.25%)  0/396 (0.00%) 
Cerebrospinal fluid retention * 1  1/406 (0.25%)  0/396 (0.00%) 
Dementia Alzheimer's type * 1  1/406 (0.25%)  0/396 (0.00%) 
Dizziness * 1  1/406 (0.25%)  0/396 (0.00%) 
Encephalopathy * 1  1/406 (0.25%)  0/396 (0.00%) 
Hepatic encephalopathy * 1  1/406 (0.25%)  0/396 (0.00%) 
Partial seizures * 1  1/406 (0.25%)  0/396 (0.00%) 
Status epilepticus * 1  1/406 (0.25%)  0/396 (0.00%) 
Subarachnoid hemorrhage * 1  1/406 (0.25%)  0/396 (0.00%) 
Cerebral hemorrhage * 1  0/406 (0.00%)  1/396 (0.25%) 
Nerve compression * 1  0/406 (0.00%)  1/396 (0.25%) 
Psychiatric disorders     
Bipolar disorder * 1  1/406 (0.25%)  0/396 (0.00%) 
Completed suicide * 1  1/406 (0.25%)  0/396 (0.00%) 
Agitation * 1  0/406 (0.00%)  1/396 (0.25%) 
Anxiety * 1  0/406 (0.00%)  1/396 (0.25%) 
Suicide attempt * 1  0/406 (0.00%)  1/396 (0.25%) 
Renal and urinary disorders     
Hematuria * 1  6/406 (1.48%)  8/396 (2.02%) 
Urinary Bladder Hemorrhage * 1  3/406 (0.74%)  0/396 (0.00%) 
Renal Failure Acute * 1  2/406 (0.49%)  2/396 (0.51%) 
Urinary retention * 1  1/406 (0.25%)  1/396 (0.25%) 
Calculus ureteric * 1  0/406 (0.00%)  2/396 (0.51%) 
Nephrolithiasis * 1  1/406 (0.25%)  0/396 (0.00%) 
Renal colic * 1  1/406 (0.25%)  0/396 (0.00%) 
Ureteric obstruction * 1  1/406 (0.25%)  0/396 (0.00%) 
Acute prerenal failure * 1  0/406 (0.00%)  1/396 (0.25%) 
Bladder perforation * 1  0/406 (0.00%)  1/396 (0.25%) 
Renal failure chronic * 1  0/406 (0.00%)  1/396 (0.25%) 
Renal impairment * 1  0/406 (0.00%)  1/396 (0.25%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease * 1  5/406 (1.23%)  4/396 (1.01%) 
Respiratory Failure * 1  3/406 (0.74%)  3/396 (0.76%) 
Pulmonary Embolism * 1  1/406 (0.25%)  3/396 (0.76%) 
Acute Respiratory Failure * 1  1/406 (0.25%)  2/396 (0.51%) 
Status asthmaticus * 1  0/406 (0.00%)  1/396 (0.25%) 
Skin and subcutaneous tissue disorders     
Diabetic foot * 1  1/406 (0.25%)  0/396 (0.00%) 
Psoriasis * 1  1/406 (0.25%)  0/396 (0.00%) 
Surgical and medical procedures     
Hip Arthroplasty * 1  4/406 (0.99%)  2/396 (0.51%) 
Knee Arthroplasty * 1  3/406 (0.74%)  4/396 (1.01%) 
Cardiac rehabilitation therapy * 1  1/406 (0.25%)  1/396 (0.25%) 
Abdominal hernia repair * 1  1/406 (0.25%)  0/396 (0.00%) 
Angioplasty * 1  1/406 (0.25%)  0/396 (0.00%) 
Aortic aneurysm repair * 1  1/406 (0.25%)  0/396 (0.00%) 
Aortic valve replacement * 1  1/406 (0.25%)  0/396 (0.00%) 
Carotid endarterectomy * 1  1/406 (0.25%)  0/396 (0.00%) 
Coronary arterial stent insertion * 1  1/406 (0.25%)  0/396 (0.00%) 
Mitral valve replacement * 1  1/406 (0.25%)  0/396 (0.00%) 
Penile prosthesis insertion * 1  1/406 (0.25%)  0/396 (0.00%) 
Salpingo-oophorectomy * 1  1/406 (0.25%)  0/396 (0.00%) 
Spinal fusion surgery * 1  1/406 (0.25%)  0/396 (0.00%) 
Bladder neoplasm surgery * 1  0/406 (0.00%)  1/396 (0.25%) 
Implantable defibrillator insertion * 1  0/406 (0.00%)  1/396 (0.25%) 
Radical prostatectomy * 1  0/406 (0.00%)  1/396 (0.25%) 
Ventriculo-peritoneal shunt * 1  0/406 (0.00%)  1/396 (0.25%) 
Vascular disorders     
Aortic aneurysm * 1  1/406 (0.25%)  1/396 (0.25%) 
Hypotension * 1  0/406 (0.00%)  2/396 (0.51%) 
Labile hypertension * 1  1/406 (0.25%)  0/396 (0.00%) 
Peripheral artery aneurysm * 1  1/406 (0.25%)  0/396 (0.00%) 
Thrombophlebitis * 1  1/406 (0.25%)  0/396 (0.00%) 
Hypertension * 1  0/406 (0.00%)  1/396 (0.25%) 
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apaziquone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   312/406 (76.85%)   285/396 (71.97%) 
Gastrointestinal disorders     
Nausea * 1  16/406 (3.94%)  19/396 (4.80%) 
Infections and infestations     
Urinary tract infection * 1  70/406 (17.24%)  58/396 (14.65%) 
Injury, poisoning and procedural complications     
Procedural pain * 1  31/406 (7.64%)  27/396 (6.82%) 
Renal and urinary disorders     
Bladder pain * 1  22/406 (5.42%)  18/396 (4.55%) 
Bladder spasm * 1  29/406 (7.14%)  23/396 (5.81%) 
Dysuria * 1  74/406 (18.23%)  67/396 (16.92%) 
Haematuria * 1  38/406 (9.36%)  57/396 (14.39%) 
Micturition urgency * 1  31/406 (7.64%)  37/396 (9.34%) 
Pollakiuria * 1  39/406 (9.61%)  46/396 (11.62%) 
Urinary retention * 1  17/406 (4.19%)  30/396 (7.58%) 
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
First publication is the multi-center publication of Study results from all study sites. Other than the multi-center publication, site may publish an independent publication of data generated by site subject to Sponsor review rights (e.g., review for intellectual property, confidentiality).
Results Point of Contact
Name/Title: Gajanan Bhat, PhD
Organization: Spectrum Pharmaceuticals
Phone: 949-743-9219
Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00461591     History of Changes
Other Study ID Numbers: SPI-611
First Submitted: April 16, 2007
First Posted: April 18, 2007
Results First Submitted: July 14, 2017
Results First Posted: August 15, 2017
Last Update Posted: October 9, 2017