Trial · NCT00118040
Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer
NCT00118040, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer. Trials, record NCT00118040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118040
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer
- NCT number
- NCT00118040
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Bladder Carcinoma, Stage I Bladder Cancer AJCC v6 and v7, Stage II Bladder Cancer AJCC v6 and v7, Stage III Bladder Cancer AJCC v6 and v7
- Interventions
- Genistein, Laboratory Biomarker Analysis, Pharmacological Study, Placebo Administration, Therapeutic Conventional Surgery
- First posted
- 2005-07-11
- Last updated
- 2021-06-10
- Results first posted
- 2016-03-24
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | up to 21 days | Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Primary | pEGFR in Benign Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, pEGFR, in the benign tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Secondary | BLCA-4 in Urine by Visit | up to 21 days | Detecting the mean amount of the biomarker BLCA-4 in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker. |
| Secondary | Survivin in Urine by Visit (pg/ml) | up to 21 days | Detecting the mean amount of the biomarker Survivin in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker. |
| Secondary | Survivin in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, Survivin, in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Secondary | EGFR Mutations in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of EGFR mutations in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Secondary | EGFR in Benign Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, EGFR, in the benign tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Secondary | Ki-67 in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, Ki-67, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Secondary | Activated Caspase 3 in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, Activated Caspase 3, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
| Secondary | COX2 in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, COX2, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | up to 21 days | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome. | percentage of pEGFR strength signal | NUMBER |
| SECONDARY | BLCA-4 in Urine by Visit | up to 21 days | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 17 for this outcome. | pg/ml | MEAN |
| SECONDARY | Survivin in Urine by Visit (pg/ml) | up to 21 days | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 16 for this outcome. | pg/ml | MEAN |
| SECONDARY | Survivin in Tumor Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome. | percentage of Survivin strength signal | NUMBER |
| SECONDARY | EGFR Mutations in Tumor Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome. | percentage of EGFR strength signal | NUMBER |
| PRIMARY | pEGFR in Benign Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. | percentage of pEGFR strength signal | NUMBER |
| SECONDARY | EGFR in Benign Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. | percentage of EGFR strength signal | NUMBER |
| SECONDARY | Ki-67 in Tumor Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome. | percentage of Ki-67 strength signal | NUMBER |
| SECONDARY | Activated Caspase 3 in Tumor Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome. | percentage of Caspase 3 strength signal | NUMBER |
| SECONDARY | COX2 in Tumor Tissue | up to 21 days on Study Drug | For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome. | percentage of COX2 strength signal | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group216
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm I (300mg Genistein) | Strong | 52.63 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm II (600mg Genistein) | Strong | 83.33 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm III (Placebo) | Strong | 93.33 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm IV (300mg Genistein + 600mg Genistein) | Strong | 67.57 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm I (300mg Genistein) | Moderate | 21.35 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm II (600mg Genistein) | Moderate | 16.67 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm III (Placebo) | Moderate | 0.00 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm IV (300mg Genistein + 600mg Genistein) | Moderate | 18.92 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm I (300mg Genistein) | Weak | 26.32 | percentage of pEGFR strength signal | |
| Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Arm II (600mg Genistein) | Weak | 0.00 | percentage of pEGFR strength signal |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (300mg Genistein) | 20 | |
| Overall Study | STARTED | Arm II (600mg Genistein) | 20 | |
| Overall Study | STARTED | Arm III (Placebo) | 20 | |
| Overall Study | COMPLETED | Arm I (300mg Genistein) | 19 | |
| Overall Study | COMPLETED | Arm II (600mg Genistein) | 18 | |
| Overall Study | COMPLETED | Arm III (Placebo) | 14 | |
| Overall Study | NOT COMPLETED | Arm I (300mg Genistein) | 1 | |
| Overall Study | NOT COMPLETED | Arm II (600mg Genistein) | 2 | |
| Overall Study | NOT COMPLETED | Arm III (Placebo) | 6 |
Source ClinicalTrials.gov
Adverse events198
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 | Fatigue | Social circumstances | Arm I (Lower Dose Genistein) | 0 | 20 | 0 |
| other | Fatigue | Social circumstances | Arm II (Higher Dose Genistein) | 1 | 20 | 1 |
| other | Fatigue | Social circumstances | Arm III (Placebo) | 0 | 20 | 0 |
| other | Sweating | Social circumstances | Arm I (Lower Dose Genistein) | 0 | 20 | 0 |
| other | Sweating | Social circumstances | Arm II (Higher Dose Genistein) | 0 | 20 | 0 |
| other | Sweating | Social circumstances | Arm III (Placebo) | 1 | 20 | 1 |
| other | Itiching | Skin and subcutaneous tissue disorders | Arm I (Lower Dose Genistein) | 1 | 20 | 1 |
| other | Itiching | Skin and subcutaneous tissue disorders | Arm II (Higher Dose Genistein) | 0 | 20 | 0 |
| other | Itiching | Skin and subcutaneous tissue disorders | Arm III (Placebo) | 0 | 20 | 0 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Arm I (Lower Dose Genistein) | 0 | 20 | 0 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Lower Dose Genistein) | ||
| Total, all-cause mortality | Arm II (Higher Dose Genistein) | ||
| Total, all-cause mortality | Arm III (Placebo) | ||
| Total, other adverse events | Arm I (Lower Dose Genistein) | 18 | 20 |
| Total, other adverse events | Arm II (Higher Dose Genistein) | 17 | 20 |
| Total, other adverse events | Arm III (Placebo) | 12 | 20 |
| Total, serious adverse events | Arm I (Lower Dose Genistein) | 1 | 20 |
| Total, serious adverse events | Arm II (Higher Dose Genistein) | 0 | 20 |
| Total, serious adverse events | Arm III (Placebo) | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22293631 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01CN035153 | PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS --261035153 | BAILEY, HOWARD H. | UNIVERSITY OF WISCONSIN - MAD | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 |
Source NIH RePORTER
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.
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