Trial · NCT01780545
Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer
NCT01780545, Phase 2, Completed, Noah Hahn, M.D.; results first posted 2017-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer. Trials, record NCT01780545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01780545
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer
- NCT number
- NCT01780545
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- Noah Hahn, M.D.
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Interventions
- OGX-427, Docetaxel
- First posted
- 2013-01-31
- Last updated
- 2022-07-11
- Results first posted
- 2017-11-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 36 Months | To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone. |
| Secondary | Safety and Toxicity of Regimen | 36 Months | To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. A summary of per-patient maxiumy grade adverse events of any type is included in the Outcome Measure. Full adverse event information will be submitted further in the record. |
| Secondary | Overall Response Rate | Every 6 weeks | To compare overall response rate (ORR) between the treatment arms. |
| Secondary | Overall Survival (OS) According to Baseline Serum Hsp27 Level. | 36 months | A subgroup analysis to determine the median overall survival time based on baseline Hsp27 levels. |
| Secondary | Hsp27 Expression in Archival Tissue | Cycle 1 | To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes. |
| Secondary | Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity | Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5 | To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 36 Months | months | MEDIAN | |
| SECONDARY | Safety and Toxicity of Regimen | 36 Months | 190 participants who intiated protocol treatment were included in the safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate | Every 6 weeks | Data for this secondary outcome measure was not collected nor analyzed. | ||
| SECONDARY | Overall Survival (OS) According to Baseline Serum Hsp27 Level. | 36 months | Subjects with a baseline Hsp27 level were included in this subgroup analysis | months | MEDIAN |
| SECONDARY | Hsp27 Expression in Archival Tissue | Cycle 1 | Data for this secondary outcome was not collected or analyzed. | ||
| SECONDARY | Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity | Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5 | Data for this secondary objective was not collected or analyzed. |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Experimental Arm: Arm A | 6.4 | 95% Confidence Interval 4.6 to 9.2 | months | |
| Overall Survival | Control Arm: Arm B | 5.9 | 95% Confidence Interval 4.8 to 7.3 | months | |
| Safety and Toxicity of Regimen | Experimental Arm: Arm A | Maximum AE Grade: 0 | 0 | Participants | |
| Safety and Toxicity of Regimen | Control Arm: Arm B | Maximum AE Grade: 0 | 2 | Participants | |
| Safety and Toxicity of Regimen | Experimental Arm: Arm A | Maximum AE Grade: 1 | 6 | Participants | |
| Safety and Toxicity of Regimen | Control Arm: Arm B | Maximum AE Grade: 1 | 7 | Participants | |
| Safety and Toxicity of Regimen | Experimental Arm: Arm A | Maximum AE Grade: 2 | 11 | Participants | |
| Safety and Toxicity of Regimen | Control Arm: Arm B | Maximum AE Grade: 2 | 15 | Participants | |
| Safety and Toxicity of Regimen | Experimental Arm: Arm A | Maximum AE Grade: 3 | 40 | Participants | |
| Safety and Toxicity of Regimen | Control Arm: Arm B | Maximum AE Grade: 3 | 41 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Arm: Arm A | 99 | |
| Overall Study | STARTED | Control Arm: Arm B | 101 | |
| Overall Study | COMPLETED | Experimental Arm: Arm A | 95 | |
| Overall Study | COMPLETED | Control Arm: Arm B | 99 | |
| Overall Study | NOT COMPLETED | Experimental Arm: Arm A | 4 | |
| Overall Study | NOT COMPLETED | Control Arm: Arm B | 2 |
Source ClinicalTrials.gov
Adverse events662
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 | ABDOMINAL DISTENSION | Gastrointestinal disorders | Experimental Arm: Arm A | 2 | 99 | 2 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Control Arm: Arm B | 2 | 101 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Experimental Arm: Arm A | 28 | 99 | 40 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Control Arm: Arm B | 13 | 101 | 15 |
| other | ACIDOSIS | Metabolism and nutrition disorders | Experimental Arm: Arm A | 1 | 99 | 1 |
| other | ACIDOSIS | Metabolism and nutrition disorders | Control Arm: Arm B | 0 | 101 | 0 |
| other | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Experimental Arm: Arm A | 3 | 99 | 4 |
| other | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Control Arm: Arm B | 0 | 101 | 0 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Experimental Arm: Arm A | 1 | 99 | 1 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Control Arm: Arm B | 1 | 101 | 1 |
1 to 10 of 662Source ClinicalTrials.gov
See all 662 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Arm: Arm A | 78 | 99 |
| Total, all-cause mortality | Control Arm: Arm B | 86 | 101 |
| Total, other adverse events | Experimental Arm: Arm A | 94 | 99 |
| Total, other adverse events | Control Arm: Arm B | 93 | 101 |
| Total, serious adverse events | Experimental Arm: Arm A | 56 | 99 |
| Total, serious adverse events | Control Arm: Arm B | 45 | 101 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Arm: Arm A vs Control Arm: Arm B: deaths from any cause | Trial comparisons |
| Experimental Arm: Arm A vs Control Arm: Arm B: serious adverse events | Trial comparisons |
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/NCT01780545
GET https://conductscience.org/api/trials/v1/NCT01780545/events?page=2