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
Conditions
Brief summary
Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how genistein or placebo works in patients with bladder cancer. This randomized phase II trial is studying genistein or placebo to compare how they work in patients who are undergoing surgery for bladder cancer.
Detailed description
PRIMARY OBJECTIVES: I. To measure the effect of G-2535 on EGF-R phosphorylation. Two EGF-R phosphorylation sites with functional significance are phosphotyrosine 992, which is a direct binding site for the PLC-gamma SH2 domain, and phosphotyrosine 1068, a binding site for the Grb2/SH2 domain. The expression of EGF-R and phosphorylated EGF-R will be determined in tumors as well as adjacent and remote normal appearing urothelium. SECONDARY OBJECTIVES: I. Measuring tissue intermediate endpoint biomarkers such as EGF-R mutations (EGFR vIII, exon 19-21), Ki67, activated Caspase 3, Akt, P-Akt, MAP kinase, P-MAP kinase, COX-2, survivin, and BLCA-4 and we will also determine survivin and BLCA-4 levels in urine specimens as surrogate tumor markers. Biomarkers associated with the EGF-R pathway, including Akt and P-Akt will be studied by immunohistochemistry. Additionally, Ki67, activated Caspase 3 (as a marker of apoptosis), and COX-2 will serve as biological endpoint biomarkers to measure the effects of G-2535 on proliferation, apoptosis, and other processes and molecules relevant to bladder cancer. These studies will be performed on tumors as well as adjacent and remote normal urothelium. II. Safety will also be studied. OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to invasiveness of disease (non-invasive \[stage Ta, Tis, or T1\] vs invasive \[stage T2, T3, or T4\]). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive oral genistein twice daily for approximately 14-30 days. Arm II: Patients receive oral genistein as in arm I but at a higher dose. Arm III: Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy. Patients undergo blood, urine, and tissue sample collection for pharmacogenomic, pharmacokinetic, and biomarker laboratory studies. Blood and urine samples are collected at baseline, after 1 week of treatment, and at the time of surgery for pharmacokinetic and urine biomarker (survivin and BLCA-4) studies. Pharmacogenomic studies (epidermal growth factor receptor \[EGFR\] polymorphisms and CYP3A 4/5 genotypes) are performed at baseline using blood samples. Tissue biomarker (EGFR polymorphism, EGFR mutations \[EGFR vIII, exon 19-21\], EGFR, phosphorylated EGFR, Ki67, activated caspase 3, Akt, P-Akt, MAP kinase, P-MAP kinase, COX-2, survivin, and BLCA4) studies using tumor tissue and adjacent and remote normal urothelium are performed at baseline and at the completion of treatment. PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.
Interventions
DRUGGenistein
Given orally
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERPharmacological Study
Correlative studies
OTHERPlacebo Administration
Given orally
PROCEDURETherapeutic Conventional Surgery
Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants eligible for this study will have been evaluated by diagnostic office cystoscopy and found to have a bladder tumor; enrollment (signing of the consent form) must be within 60 days of pre-study cystoscopy demonstrating bladder tumor; the participant should have no evidence of distant metastasis and the primary tumor may represent either an initial diagnosis or recurrent disease of any clinical stage. Study participants must also be candidates for either subsequent cystoscopy/transurethral resection of bladder tumor (TURBT) or complete or partical cystectomy; histologic diagnosis is not required for enrollment; pre-enrollment diagnostic cystoscopy must be at least 45 days after treatment of the bladder with other agents such as BCG (participants with recurrent disease) * ECOG performance status 0 or 1 * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Ability to understand and the willingness to sign a written informed consent document * WBC \>= 3000/mm\^3 * Platelets \>= 100,000mm\^3 * Hemoglobin \>= 10 g/dL * Bilirubin =\< 1.4 mg/dl * AST =\< 3x normal * Creatinine =\< 2.0mg/dl * Serum calcium =\< 10.2 mg/dl, * Amylase =\< 3 x normal * Na \>= 125 and =\< 155 mmol/L * K \>= 3.2 and =\< 6 mmol/L * Cl \>= 85 and =\< 114 mmol/L * CO2 \>= 11 mEQ/dL * TSH within 1.3 x the upper range of normal and normal T4 * Females of child-bearing potential must have a negative pregnancy test; patients who have had a bilateral oophorectomy, hysterectomy, are greater than 1 year since their last menses, or are greater than 51 years of age are not considered to be of child-baring potential * Participants must agree to stop soy supplements before enrolling in the study * Patients must agree to stop taking NSAIDS before enrolling in the study; patients may, however, take cardioprotective doses of aspirin equal to or less than 81mg per day
Exclusion criteria
* Participant may not have received other treatment for bladder cancer between the pre-enrollment cystoscopy and subsequent surgery * Participants may not be receiving any other investigational agents * Participant may not have received prior pelvic irradiation for any reason * Participant may not be receiving concurrent systemic cancer treatment for other cancers * Participant may not be taking concurrent soy supplements while on the study medication * Participant may not be taking concurrent NSAIDS (aspirin doses of =\< 81 mg acceptable) while on the study medication * Participant may not be taking thyroid medications * History of allergic reactions attributed to compounds of similar chemical or biologic composition to genistein, soy isoflavones or other allergies to soy-based products will render a participant ineligible * Uncontrolled concurrent illness will render a participant ineligible including, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unregulated cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women may not be pregnant or lactating; the effects of G-2535 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| AKT in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, AKT, 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. |
| pAKT in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, pAKT, 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. |
| MAP Kinase in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, MAP Kinase, 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. |
| pMAP Kinase in Tumor Tissue | up to 21 days on Study Drug | Detecting the signal of the biomarker, pMAP Kinase, 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited during a 3 year period by staff at 7 participating institutions (both University hospitals and community clinics).
Participants by arm
| Arm | Count |
|---|---|
| Arm I (300mg Genistein) Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy. | 20 |
| Arm II (600mg Genistein) Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy. | 20 |
| Arm III (Placebo) Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Medical Contraindication | 0 | 0 | 1 |
| Overall Study | Non-Compliant Participant | 1 | 1 | 2 |
| Overall Study | Other | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Arm III (Placebo) | Total | Arm I (300mg Genistein) | Arm II (600mg Genistein) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 38 Participants | 12 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 22 Participants | 8 Participants | 7 Participants |
| Age, Continuous | 71.95 years STANDARD_DEVIATION 12.67 | 69.73 years STANDARD_DEVIATION 10.4 | 68.60 years STANDARD_DEVIATION 9.16 | 68.65 years STANDARD_DEVIATION 9.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 60 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 60 Participants | 20 Participants | 20 Participants |
| Region of Enrollment United States | 20 participants | 60 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 18 Participants | 52 Participants | 15 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 20 | 17 / 20 | 12 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Time frame: up to 21 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Strong | 52.63 percentage of pEGFR strength signal |
| Arm I (300mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Moderate | 21.35 percentage of pEGFR strength signal |
| Arm I (300mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Weak | 26.32 percentage of pEGFR strength signal |
| Arm I (300mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Negative | 0.00 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Moderate | 16.67 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Weak | 0.00 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Negative | 0.00 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Strong | 83.33 percentage of pEGFR strength signal |
| Arm III (Placebo) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Weak | 6.67 percentage of pEGFR strength signal |
| Arm III (Placebo) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Moderate | 0.00 percentage of pEGFR strength signal |
| Arm III (Placebo) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Negative | 0.00 percentage of pEGFR strength signal |
| Arm III (Placebo) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Strong | 93.33 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Negative | 0.00 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Moderate | 18.92 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Strong | 67.57 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment | Weak | 13.51 percentage of pEGFR strength signal |
Primary
pEGFR in Benign Tissue
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.
Time frame: up to 21 days on Study Drug
Population: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | pEGFR in Benign Tissue | Strong | 4.55 percentage of pEGFR strength signal |
| Arm I (300mg Genistein) | pEGFR in Benign Tissue | Moderate | 27.27 percentage of pEGFR strength signal |
| Arm I (300mg Genistein) | pEGFR in Benign Tissue | Weak | 54.55 percentage of pEGFR strength signal |
| Arm I (300mg Genistein) | pEGFR in Benign Tissue | Negative | 13.64 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | pEGFR in Benign Tissue | Moderate | 33.33 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | pEGFR in Benign Tissue | Weak | 44.44 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | pEGFR in Benign Tissue | Negative | 22.22 percentage of pEGFR strength signal |
| Arm II (600mg Genistein) | pEGFR in Benign Tissue | Strong | 0.00 percentage of pEGFR strength signal |
| Arm III (Placebo) | pEGFR in Benign Tissue | Weak | 57.14 percentage of pEGFR strength signal |
| Arm III (Placebo) | pEGFR in Benign Tissue | Moderate | 28.57 percentage of pEGFR strength signal |
| Arm III (Placebo) | pEGFR in Benign Tissue | Negative | 7.14 percentage of pEGFR strength signal |
| Arm III (Placebo) | pEGFR in Benign Tissue | Strong | 7.14 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pEGFR in Benign Tissue | Negative | 25.00 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pEGFR in Benign Tissue | Moderate | 25.00 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pEGFR in Benign Tissue | Strong | 0.00 percentage of pEGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pEGFR in Benign Tissue | Weak | 50.00 percentage of pEGFR strength signal |
Secondary
Activated Caspase 3 in Tumor Tissue
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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | Activated Caspase 3 in Tumor Tissue | Negative | 59.46 percentage of Caspase 3 strength signal |
| Arm I (300mg Genistein) | Activated Caspase 3 in Tumor Tissue | Weak | 27.03 percentage of Caspase 3 strength signal |
| Arm I (300mg Genistein) | Activated Caspase 3 in Tumor Tissue | Strong | 10.81 percentage of Caspase 3 strength signal |
| Arm I (300mg Genistein) | Activated Caspase 3 in Tumor Tissue | Moderate | 2.70 percentage of Caspase 3 strength signal |
| Arm II (600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Moderate | 6.67 percentage of Caspase 3 strength signal |
| Arm II (600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Strong | 0.00 percentage of Caspase 3 strength signal |
| Arm II (600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Weak | 26.67 percentage of Caspase 3 strength signal |
| Arm II (600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Negative | 66.67 percentage of Caspase 3 strength signal |
| Arm III (Placebo) | Activated Caspase 3 in Tumor Tissue | Weak | 26.32 percentage of Caspase 3 strength signal |
| Arm III (Placebo) | Activated Caspase 3 in Tumor Tissue | Negative | 63.16 percentage of Caspase 3 strength signal |
| Arm III (Placebo) | Activated Caspase 3 in Tumor Tissue | Moderate | 0.00 percentage of Caspase 3 strength signal |
| Arm III (Placebo) | Activated Caspase 3 in Tumor Tissue | Strong | 10.53 percentage of Caspase 3 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Negative | 55.56 percentage of Caspase 3 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Strong | 11.11 percentage of Caspase 3 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Moderate | 5.56 percentage of Caspase 3 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Activated Caspase 3 in Tumor Tissue | Weak | 27.78 percentage of Caspase 3 strength signal |
Secondary
AKT in Tumor Tissue
Detecting the signal of the biomarker, AKT, 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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | AKT in Tumor Tissue | Strong | 64.86 percentage of AKT strength signal |
| Arm I (300mg Genistein) | AKT in Tumor Tissue | Moderate | 10.81 percentage of AKT strength signal |
| Arm I (300mg Genistein) | AKT in Tumor Tissue | Weak | 18.92 percentage of AKT strength signal |
| Arm I (300mg Genistein) | AKT in Tumor Tissue | Negative | 5.41 percentage of AKT strength signal |
| Arm II (600mg Genistein) | AKT in Tumor Tissue | Moderate | 13.33 percentage of AKT strength signal |
| Arm II (600mg Genistein) | AKT in Tumor Tissue | Weak | 20.00 percentage of AKT strength signal |
| Arm II (600mg Genistein) | AKT in Tumor Tissue | Negative | 6.67 percentage of AKT strength signal |
| Arm II (600mg Genistein) | AKT in Tumor Tissue | Strong | 60.00 percentage of AKT strength signal |
| Arm III (Placebo) | AKT in Tumor Tissue | Weak | 10.53 percentage of AKT strength signal |
| Arm III (Placebo) | AKT in Tumor Tissue | Moderate | 5.26 percentage of AKT strength signal |
| Arm III (Placebo) | AKT in Tumor Tissue | Negative | 5.26 percentage of AKT strength signal |
| Arm III (Placebo) | AKT in Tumor Tissue | Strong | 78.95 percentage of AKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | AKT in Tumor Tissue | Negative | 5.56 percentage of AKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | AKT in Tumor Tissue | Moderate | 16.67 percentage of AKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | AKT in Tumor Tissue | Strong | 50.00 percentage of AKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | AKT in Tumor Tissue | Weak | 27.78 percentage of AKT strength signal |
Secondary
BLCA-4 in Urine by Visit
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.
Time frame: up to 21 days
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (300mg Genistein) | BLCA-4 in Urine by Visit | Baseline | 0.54 pg/ml | Standard Deviation 0.35 |
| Arm I (300mg Genistein) | BLCA-4 in Urine by Visit | Pre-Surgery | 0.52 pg/ml | Standard Deviation 0.36 |
| Arm I (300mg Genistein) | BLCA-4 in Urine by Visit | Day 8 | 0.52 pg/ml | Standard Deviation 0.42 |
| Arm II (600mg Genistein) | BLCA-4 in Urine by Visit | Baseline | 0.46 pg/ml | Standard Deviation 0.24 |
| Arm II (600mg Genistein) | BLCA-4 in Urine by Visit | Pre-Surgery | 0.49 pg/ml | Standard Deviation 0.34 |
| Arm II (600mg Genistein) | BLCA-4 in Urine by Visit | Day 8 | 0.53 pg/ml | Standard Deviation 0.2 |
| Arm III (Placebo) | BLCA-4 in Urine by Visit | Day 8 | 0.54 pg/ml | Standard Deviation 0.42 |
| Arm III (Placebo) | BLCA-4 in Urine by Visit | Baseline | 0.52 pg/ml | Standard Deviation 0.37 |
| Arm III (Placebo) | BLCA-4 in Urine by Visit | Pre-Surgery | 0.59 pg/ml | Standard Deviation 0.39 |
| Arm IV (300mg Genistein + 600mg Genistein) | BLCA-4 in Urine by Visit | Baseline | 0.55 pg/ml | Standard Deviation 0.34 |
| Arm IV (300mg Genistein + 600mg Genistein) | BLCA-4 in Urine by Visit | Pre-Surgery | 0.44 pg/ml | Standard Deviation 0.31 |
| Arm IV (300mg Genistein + 600mg Genistein) | BLCA-4 in Urine by Visit | Day 8 | 0.50 pg/ml | Standard Deviation 0.43 |
Secondary
COX2 in Tumor Tissue
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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | COX2 in Tumor Tissue | Strong | 13.51 percentage of COX2 strength signal |
| Arm I (300mg Genistein) | COX2 in Tumor Tissue | Moderate | 32.43 percentage of COX2 strength signal |
| Arm I (300mg Genistein) | COX2 in Tumor Tissue | Weak | 16.22 percentage of COX2 strength signal |
| Arm I (300mg Genistein) | COX2 in Tumor Tissue | Negative | 37.84 percentage of COX2 strength signal |
| Arm II (600mg Genistein) | COX2 in Tumor Tissue | Moderate | 26.67 percentage of COX2 strength signal |
| Arm II (600mg Genistein) | COX2 in Tumor Tissue | Weak | 33.33 percentage of COX2 strength signal |
| Arm II (600mg Genistein) | COX2 in Tumor Tissue | Negative | 40.00 percentage of COX2 strength signal |
| Arm II (600mg Genistein) | COX2 in Tumor Tissue | Strong | 0.00 percentage of COX2 strength signal |
| Arm III (Placebo) | COX2 in Tumor Tissue | Weak | 5.26 percentage of COX2 strength signal |
| Arm III (Placebo) | COX2 in Tumor Tissue | Moderate | 36.84 percentage of COX2 strength signal |
| Arm III (Placebo) | COX2 in Tumor Tissue | Negative | 42.11 percentage of COX2 strength signal |
| Arm III (Placebo) | COX2 in Tumor Tissue | Strong | 15.79 percentage of COX2 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | COX2 in Tumor Tissue | Negative | 33.33 percentage of COX2 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | COX2 in Tumor Tissue | Moderate | 27.78 percentage of COX2 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | COX2 in Tumor Tissue | Strong | 11.11 percentage of COX2 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | COX2 in Tumor Tissue | Weak | 27.78 percentage of COX2 strength signal |
Secondary
EGFR in Benign Tissue
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.
Time frame: up to 21 days on Study Drug
Population: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | EGFR in Benign Tissue | Strong | 40.91 percentage of EGFR strength signal |
| Arm I (300mg Genistein) | EGFR in Benign Tissue | Moderate | 13.64 percentage of EGFR strength signal |
| Arm I (300mg Genistein) | EGFR in Benign Tissue | Weak | 9.09 percentage of EGFR strength signal |
| Arm I (300mg Genistein) | EGFR in Benign Tissue | Negative | 36.36 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR in Benign Tissue | Moderate | 22.22 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR in Benign Tissue | Weak | 0.00 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR in Benign Tissue | Negative | 66.67 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR in Benign Tissue | Strong | 11.11 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR in Benign Tissue | Weak | 14.29 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR in Benign Tissue | Moderate | 7.14 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR in Benign Tissue | Negative | 35.71 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR in Benign Tissue | Strong | 42.86 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR in Benign Tissue | Negative | 37.50 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR in Benign Tissue | Moderate | 25.00 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR in Benign Tissue | Strong | 37.50 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR in Benign Tissue | Weak | 0.00 percentage of EGFR strength signal |
Secondary
EGFR Mutations in Tumor Tissue
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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | EGFR Mutations in Tumor Tissue | Strong | 48.65 percentage of EGFR strength signal |
| Arm I (300mg Genistein) | EGFR Mutations in Tumor Tissue | Moderate | 16.22 percentage of EGFR strength signal |
| Arm I (300mg Genistein) | EGFR Mutations in Tumor Tissue | Weak | 16.22 percentage of EGFR strength signal |
| Arm I (300mg Genistein) | EGFR Mutations in Tumor Tissue | Negative | 18.92 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR Mutations in Tumor Tissue | Moderate | 0.00 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR Mutations in Tumor Tissue | Weak | 6.67 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR Mutations in Tumor Tissue | Negative | 46.67 percentage of EGFR strength signal |
| Arm II (600mg Genistein) | EGFR Mutations in Tumor Tissue | Strong | 46.67 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR Mutations in Tumor Tissue | Weak | 21.05 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR Mutations in Tumor Tissue | Moderate | 10.53 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR Mutations in Tumor Tissue | Negative | 26.32 percentage of EGFR strength signal |
| Arm III (Placebo) | EGFR Mutations in Tumor Tissue | Strong | 42.11 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR Mutations in Tumor Tissue | Negative | 11.11 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR Mutations in Tumor Tissue | Moderate | 22.22 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR Mutations in Tumor Tissue | Strong | 55.56 percentage of EGFR strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | EGFR Mutations in Tumor Tissue | Weak | 11.11 percentage of EGFR strength signal |
Secondary
Ki-67 in Tumor Tissue
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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | Ki-67 in Tumor Tissue | Strong | 40.54 percentage of Ki-67 strength signal |
| Arm I (300mg Genistein) | Ki-67 in Tumor Tissue | Moderate | 18.92 percentage of Ki-67 strength signal |
| Arm I (300mg Genistein) | Ki-67 in Tumor Tissue | Weak | 35.14 percentage of Ki-67 strength signal |
| Arm I (300mg Genistein) | Ki-67 in Tumor Tissue | Negative | 5.41 percentage of Ki-67 strength signal |
| Arm II (600mg Genistein) | Ki-67 in Tumor Tissue | Moderate | 20.00 percentage of Ki-67 strength signal |
| Arm II (600mg Genistein) | Ki-67 in Tumor Tissue | Weak | 46.67 percentage of Ki-67 strength signal |
| Arm II (600mg Genistein) | Ki-67 in Tumor Tissue | Negative | 6.67 percentage of Ki-67 strength signal |
| Arm II (600mg Genistein) | Ki-67 in Tumor Tissue | Strong | 26.67 percentage of Ki-67 strength signal |
| Arm III (Placebo) | Ki-67 in Tumor Tissue | Weak | 31.58 percentage of Ki-67 strength signal |
| Arm III (Placebo) | Ki-67 in Tumor Tissue | Moderate | 15.79 percentage of Ki-67 strength signal |
| Arm III (Placebo) | Ki-67 in Tumor Tissue | Negative | 5.26 percentage of Ki-67 strength signal |
| Arm III (Placebo) | Ki-67 in Tumor Tissue | Strong | 47.37 percentage of Ki-67 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Ki-67 in Tumor Tissue | Negative | 5.56 percentage of Ki-67 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Ki-67 in Tumor Tissue | Moderate | 22.22 percentage of Ki-67 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Ki-67 in Tumor Tissue | Strong | 33.33 percentage of Ki-67 strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Ki-67 in Tumor Tissue | Weak | 38.89 percentage of Ki-67 strength signal |
Secondary
MAP Kinase in Tumor Tissue
Detecting the signal of the biomarker, MAP Kinase, 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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | MAP Kinase in Tumor Tissue | Strong | 75.68 percentage of MAP Kinase strength signal |
| Arm I (300mg Genistein) | MAP Kinase in Tumor Tissue | Moderate | 16.22 percentage of MAP Kinase strength signal |
| Arm I (300mg Genistein) | MAP Kinase in Tumor Tissue | Weak | 2.70 percentage of MAP Kinase strength signal |
| Arm I (300mg Genistein) | MAP Kinase in Tumor Tissue | Negative | 5.41 percentage of MAP Kinase strength signal |
| Arm II (600mg Genistein) | MAP Kinase in Tumor Tissue | Moderate | 6.67 percentage of MAP Kinase strength signal |
| Arm II (600mg Genistein) | MAP Kinase in Tumor Tissue | Weak | 0.00 percentage of MAP Kinase strength signal |
| Arm II (600mg Genistein) | MAP Kinase in Tumor Tissue | Negative | 6.67 percentage of MAP Kinase strength signal |
| Arm II (600mg Genistein) | MAP Kinase in Tumor Tissue | Strong | 86.67 percentage of MAP Kinase strength signal |
| Arm III (Placebo) | MAP Kinase in Tumor Tissue | Weak | 0.00 percentage of MAP Kinase strength signal |
| Arm III (Placebo) | MAP Kinase in Tumor Tissue | Moderate | 10.53 percentage of MAP Kinase strength signal |
| Arm III (Placebo) | MAP Kinase in Tumor Tissue | Negative | 5.26 percentage of MAP Kinase strength signal |
| Arm III (Placebo) | MAP Kinase in Tumor Tissue | Strong | 84.21 percentage of MAP Kinase strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | MAP Kinase in Tumor Tissue | Negative | 5.56 percentage of MAP Kinase strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | MAP Kinase in Tumor Tissue | Moderate | 22.22 percentage of MAP Kinase strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | MAP Kinase in Tumor Tissue | Strong | 66.67 percentage of MAP Kinase strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | MAP Kinase in Tumor Tissue | Weak | 5.56 percentage of MAP Kinase strength signal |
Secondary
pAKT in Tumor Tissue
Detecting the signal of the biomarker, pAKT, 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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | pAKT in Tumor Tissue | Strong | 43.24 percentage of pAKT strength signal |
| Arm I (300mg Genistein) | pAKT in Tumor Tissue | Moderate | 8.11 percentage of pAKT strength signal |
| Arm I (300mg Genistein) | pAKT in Tumor Tissue | Weak | 2.70 percentage of pAKT strength signal |
| Arm I (300mg Genistein) | pAKT in Tumor Tissue | Negative | 45.95 percentage of pAKT strength signal |
| Arm II (600mg Genistein) | pAKT in Tumor Tissue | Moderate | 0.00 percentage of pAKT strength signal |
| Arm II (600mg Genistein) | pAKT in Tumor Tissue | Weak | 6.67 percentage of pAKT strength signal |
| Arm II (600mg Genistein) | pAKT in Tumor Tissue | Negative | 60.00 percentage of pAKT strength signal |
| Arm II (600mg Genistein) | pAKT in Tumor Tissue | Strong | 33.33 percentage of pAKT strength signal |
| Arm III (Placebo) | pAKT in Tumor Tissue | Weak | 0.00 percentage of pAKT strength signal |
| Arm III (Placebo) | pAKT in Tumor Tissue | Moderate | 5.26 percentage of pAKT strength signal |
| Arm III (Placebo) | pAKT in Tumor Tissue | Negative | 47.37 percentage of pAKT strength signal |
| Arm III (Placebo) | pAKT in Tumor Tissue | Strong | 47.37 percentage of pAKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pAKT in Tumor Tissue | Negative | 44.44 percentage of pAKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pAKT in Tumor Tissue | Moderate | 11.11 percentage of pAKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pAKT in Tumor Tissue | Strong | 38.89 percentage of pAKT strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | pAKT in Tumor Tissue | Weak | 5.56 percentage of pAKT strength signal |
Secondary
pMAP Kinase in Tumor Tissue
Detecting the signal of the biomarker, pMAP Kinase, 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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | pMAP Kinase in Tumor Tissue | Strong | 48.65 percentage of pMAP Kinase strength signa |
| Arm I (300mg Genistein) | pMAP Kinase in Tumor Tissue | Moderate | 37.84 percentage of pMAP Kinase strength signa |
| Arm I (300mg Genistein) | pMAP Kinase in Tumor Tissue | Weak | 13.51 percentage of pMAP Kinase strength signa |
| Arm I (300mg Genistein) | pMAP Kinase in Tumor Tissue | Negative | 0.00 percentage of pMAP Kinase strength signa |
| Arm II (600mg Genistein) | pMAP Kinase in Tumor Tissue | Negative | 6.67 percentage of pMAP Kinase strength signa |
| Arm II (600mg Genistein) | pMAP Kinase in Tumor Tissue | Weak | 6.67 percentage of pMAP Kinase strength signa |
| Arm II (600mg Genistein) | pMAP Kinase in Tumor Tissue | Moderate | 20.00 percentage of pMAP Kinase strength signa |
| Arm II (600mg Genistein) | pMAP Kinase in Tumor Tissue | Strong | 66.67 percentage of pMAP Kinase strength signa |
| Arm III (Placebo) | pMAP Kinase in Tumor Tissue | Weak | 21.05 percentage of pMAP Kinase strength signa |
| Arm III (Placebo) | pMAP Kinase in Tumor Tissue | Negative | 0.00 percentage of pMAP Kinase strength signa |
| Arm III (Placebo) | pMAP Kinase in Tumor Tissue | Moderate | 42.11 percentage of pMAP Kinase strength signa |
| Arm III (Placebo) | pMAP Kinase in Tumor Tissue | Strong | 36.84 percentage of pMAP Kinase strength signa |
| Arm IV (300mg Genistein + 600mg Genistein) | pMAP Kinase in Tumor Tissue | Negative | 0.00 percentage of pMAP Kinase strength signa |
| Arm IV (300mg Genistein + 600mg Genistein) | pMAP Kinase in Tumor Tissue | Strong | 61.11 percentage of pMAP Kinase strength signa |
| Arm IV (300mg Genistein + 600mg Genistein) | pMAP Kinase in Tumor Tissue | Moderate | 33.33 percentage of pMAP Kinase strength signa |
| Arm IV (300mg Genistein + 600mg Genistein) | pMAP Kinase in Tumor Tissue | Weak | 5.56 percentage of pMAP Kinase strength signa |
Secondary
Survivin in Tumor Tissue
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.
Time frame: up to 21 days on Study Drug
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (300mg Genistein) | Survivin in Tumor Tissue | Strong | 24.32 percentage of Survivin strength signal |
| Arm I (300mg Genistein) | Survivin in Tumor Tissue | Moderate | 13.51 percentage of Survivin strength signal |
| Arm I (300mg Genistein) | Survivin in Tumor Tissue | Weak | 35.14 percentage of Survivin strength signal |
| Arm I (300mg Genistein) | Survivin in Tumor Tissue | Negative | 27.03 percentage of Survivin strength signal |
| Arm II (600mg Genistein) | Survivin in Tumor Tissue | Moderate | 33.33 percentage of Survivin strength signal |
| Arm II (600mg Genistein) | Survivin in Tumor Tissue | Weak | 33.33 percentage of Survivin strength signal |
| Arm II (600mg Genistein) | Survivin in Tumor Tissue | Negative | 33.33 percentage of Survivin strength signal |
| Arm II (600mg Genistein) | Survivin in Tumor Tissue | Strong | 0.00 percentage of Survivin strength signal |
| Arm III (Placebo) | Survivin in Tumor Tissue | Weak | 26.32 percentage of Survivin strength signal |
| Arm III (Placebo) | Survivin in Tumor Tissue | Moderate | 15.79 percentage of Survivin strength signal |
| Arm III (Placebo) | Survivin in Tumor Tissue | Negative | 42.11 percentage of Survivin strength signal |
| Arm III (Placebo) | Survivin in Tumor Tissue | Strong | 15.79 percentage of Survivin strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Tumor Tissue | Negative | 11.11 percentage of Survivin strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Tumor Tissue | Moderate | 11.11 percentage of Survivin strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Tumor Tissue | Strong | 33.33 percentage of Survivin strength signal |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Tumor Tissue | Weak | 44.44 percentage of Survivin strength signal |
Secondary
Survivin in Urine by Visit (pg/ml)
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.
Time frame: up to 21 days
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (300mg Genistein) | Survivin in Urine by Visit (pg/ml) | Baseline | 58.5 pg/ml | Standard Deviation 141.3 |
| Arm I (300mg Genistein) | Survivin in Urine by Visit (pg/ml) | Pre-Surgery | 55.4 pg/ml | Standard Deviation 166.7 |
| Arm I (300mg Genistein) | Survivin in Urine by Visit (pg/ml) | Day 8 | 41.0 pg/ml | Standard Deviation 123.8 |
| Arm II (600mg Genistein) | Survivin in Urine by Visit (pg/ml) | Baseline | 16.0 pg/ml | Standard Deviation 37.4 |
| Arm II (600mg Genistein) | Survivin in Urine by Visit (pg/ml) | Pre-Surgery | 28.6 pg/ml | Standard Deviation 43.3 |
| Arm II (600mg Genistein) | Survivin in Urine by Visit (pg/ml) | Day 8 | 17.8 pg/ml | Standard Deviation 32.6 |
| Arm III (Placebo) | Survivin in Urine by Visit (pg/ml) | Day 8 | 60.3 pg/ml | Standard Deviation 175.7 |
| Arm III (Placebo) | Survivin in Urine by Visit (pg/ml) | Baseline | 71.0 pg/ml | Standard Deviation 171.7 |
| Arm III (Placebo) | Survivin in Urine by Visit (pg/ml) | Pre-Surgery | 84.4 pg/ml | Standard Deviation 237.3 |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Urine by Visit (pg/ml) | Baseline | 46.6 pg/ml | Standard Deviation 108.6 |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Urine by Visit (pg/ml) | Pre-Surgery | 29.5 pg/ml | Standard Deviation 49.6 |
| Arm IV (300mg Genistein + 600mg Genistein) | Survivin in Urine by Visit (pg/ml) | Day 8 | 23.7 pg/ml | Standard Deviation 41.1 |