Trial · NCT02563561
A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)
NCT02563561, Phase 3, Terminated, Spectrum Pharmaceuticals, Inc; results first posted 2021-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT). Trials, record NCT02563561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02563561
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)
- NCT number
- NCT02563561
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Conditions
- Bladder Cancer
- Interventions
- Apaziquone, Placebo
- First posted
- 2015-09-30
- Last updated
- 2021-10-27
- Results first posted
- 2021-09-27
- Limitations and caveats
- The study was terminated as per Sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Recurrence | From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years) | Time from randomization to the date of histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment. |
| Secondary | 2-Year Recurrence Rate | 2 years | The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before Year 2. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or CIS post-treatment. |
| Secondary | 1-Year Recurrence Rate | 1 year | The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before Year 1. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or CIS post-treatment. |
| Secondary | Time to Progression | From randomization to the date of first disease progression (up to 1.5 years) | Time to disease progression was defined as the time from randomization to the first disease progression. The development of T2 or greater disease was only included in the assessment of time to disease progression. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | Up to 1.5 Years | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. TEAEs were adverse events that occurred from the first dose of study treatment until 40 days after the last dose of study drug administration or 40 days after the date of participant early discontinuation. Treatment-related AEs included TEAEs with relationship to study treatment reported as possible, probable, definite, or missing. An SAE was an AE resulting in any of the outcomes: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Recurrence | From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | 2-Year Recurrence Rate | 2 years | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | 1-Year Recurrence Rate | 1 year | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Time to Progression | From randomization to the date of first disease progression (up to 1.5 years) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | Up to 1.5 Years | Safety Population included all randomized participants classified according to the actual treatment received, regardless of random assignment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 1 Dose Apaziquone | TEAEs | 10 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 2 Dose Apaziquone | TEAEs | 13 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | Placebo | TEAEs | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 1 Dose Apaziquone | Treatment-Related AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 2 Dose Apaziquone | Treatment-Related AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | Placebo | Treatment-Related AEs | 5 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 1 Dose Apaziquone | SAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 2 Dose Apaziquone | SAEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | Placebo | SAEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death | 1 Dose Apaziquone | TEAEs Leading to Discontinuation | 0 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 Dose Apaziquone | 19 | |
| Overall Study | STARTED | 2 Dose Apaziquone | 23 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | Safety Population | 1 Dose Apaziquone | 19 | |
| Overall Study | Safety Population | 2 Dose Apaziquone | 21 | |
| Overall Study | Safety Population | Placebo | 17 | |
| Overall Study | COMPLETED | 1 Dose Apaziquone | 1 | |
| Overall Study | COMPLETED | 2 Dose Apaziquone | 2 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | 1 Dose Apaziquone | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events87
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytosis | Blood and lymphatic system disorders | 1 Dose Apaziquone | 0 | 19 | |
| other | Leukocytosis | Blood and lymphatic system disorders | 2 Dose Apaziquone | 0 | 21 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 1 | 17 | |
| other | Adrenal Mass | Endocrine disorders | 1 Dose Apaziquone | 1 | 19 | |
| other | Adrenal Mass | Endocrine disorders | 2 Dose Apaziquone | 1 | 21 | |
| other | Adrenal Mass | Endocrine disorders | Placebo | 0 | 17 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | 1 Dose Apaziquone | 0 | 19 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | 2 Dose Apaziquone | 0 | 21 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo | 1 | 17 | |
| other | Abdominal Distension | Gastrointestinal disorders | 1 Dose Apaziquone | 1 | 19 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Dose Apaziquone | 0 | 19 |
| Total, all-cause mortality | 2 Dose Apaziquone | 0 | 21 |
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, other adverse events | 1 Dose Apaziquone | 10 | 19 |
| Total, other adverse events | 2 Dose Apaziquone | 12 | 21 |
| Total, other adverse events | Placebo | 7 | 17 |
| Total, serious adverse events | 1 Dose Apaziquone | 0 | 19 |
| Total, serious adverse events | 2 Dose Apaziquone | 2 | 21 |
| Total, serious adverse events | Placebo | 1 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02563561
GET https://conductscience.org/api/trials/v1/NCT02563561/events?page=2