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Health Condition(s) or Problem
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Prostate Cancer; Non-Hodgkins Lymphoma
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Lay Summary
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Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory
non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide
clinical benefit is available will be enrolled. Primary objectives: estimate the maximum
tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate,
pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal
elimination.
(from ClinicalTrials.gov)
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Who can enter the trial
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General
Inclusion Criteria:
1. Read, understand and sign the IRB- or IEC-approved ICF confirming his or her
willingness to participate in this trial.
2. At least 18 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
4. Adequate bone marrow function; normal renal and hepatic function, normal cardiac
function.
5. Normal cardiac function in the opinion of the investigator and supported by LVEF 50%
or greater on the screening echocardiogram (or MUGA), no significant abnormalities on
the screening ECG (eg, left bundle branch block, III degree AV block, acute
myocardial infarction, Wolff-Parkinson-White syndrome or QTc interval = 450 msec) and
no history of additional risk factors for torsades de pointes (eg, heart failure,
hypokalemia or family history of Long QT Syndrome).
Exclusion Criteria:
1. Active secondary malignancy or history of other malignancy within the last two years
except non-melanoma skin cancers or cervical carcinoma in situ.
2. History of significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure and/or myocardial infarction or any Class 3 or
4 cardiac disease as defined by the New York Heart Association Functional
Classification.
3. Received any anticancer agent(s) within the past 3 weeks, including investigational
agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic
or marketed or investigational tyrosine kinase inhibitors.
4. Received prior radiation therapy within the past 4 weeks or received irradiation of =
25% of their bone marrow reserve.
5. Any serious, uncontrolled active infection that requires systemic treatment or known
infection with HIV, HCV or HBV.
6. Symptomatic CNS metastases or lesions for which treatment is required.
Prostate Cancer
Inclusion Criteria:
1. Males with histologically confirmed adenocarcinoma of the prostate, which is now
metastatic (e.g., any T, any N, M1a-c)based on bone scan, CT scan, or MRI scan.
Demonstrated evidence of progressive disease despite androgen deprivation (androgen
ablation or surgical castration), anti-androgen withdrawal and progression of disease
after docetaxel-based therapy.
2. Demonstrated evidence of progressive disease despite androgen deprivation (androgen
ablation or surgical castration), anti-androgen withdrawal and progression of disease
after docetaxel-based therapy.
• Greater than 25% increase in 3 consecutive tests (PSA 1 < PSA 2 < PSA 3),
each PSA value separated by at least 1 week
3. Serum testosterone level = 50 ng/dL post orchiectomy or while maintained on
continuous or intermittent medical androgen suppression with a LHRH agonist or
antagonist.
4. At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide;
and at least 6 weeks since prior bicalutamide or nilutamide.
5. Systemic corticosteroids discontinued within two weeks of dosing, except low dose
regimens which may continue if unchanged
6. Strontium-89 or Samarium-153 must have been completed at least 8 weeks prior to the
first dose of therapy and recovered from all treatment-related toxicities.
Exclusion Criteria:
1. Must not be receiving concurrent anti-androgen hormonal therapy for hormone
refractory prostate cancer.
Non-Hodgkin's Lymphoma
Inclusion Criteria:
1. Histologically proven relapsed or refractory
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Who cannot enter the trial
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General
Inclusion Criteria:
1. Read, understand and sign the IRB- or IEC-approved ICF confirming his or her
willingness to participate in this trial.
2. At least 18 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
4. Adequate bone marrow function; normal renal and hepatic function, normal cardiac
function.
5. Normal cardiac function in the opinion of the investigator and supported by LVEF 50%
or greater on the screening echocardiogram (or MUGA), no significant abnormalities on
the screening ECG (eg, left bundle branch block, III degree AV block, acute
myocardial infarction, Wolff-Parkinson-White syndrome or QTc interval = 450 msec) and
no history of additional risk factors for torsades de pointes (eg, heart failure,
hypokalemia or family history of Long QT Syndrome).
Exclusion Criteria:
1. Active secondary malignancy or history of other malignancy within the last two years
except non-melanoma skin cancers or cervical carcinoma in situ.
2. History of significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure and/or myocardial infarction or any Class 3 or
4 cardiac disease as defined by the New York Heart Association Functional
Classification.
3. Received any anticancer agent(s) within the past 3 weeks, including investigational
agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic
or marketed or investigational tyrosine kinase inhibitors.
4. Received prior radiation therapy within the past 4 weeks or received irradiation of =
25% of their bone marrow reserve.
5. Any serious, uncontrolled active infection that requires systemic treatment or known
infection with HIV, HCV or HBV.
6. Symptomatic CNS metastases or lesions for which treatment is required.
Prostate Cancer
Inclusion Criteria:
1. Males with histologically confirmed adenocarcinoma of the prostate, which is now
metastatic (e.g., any T, any N, M1a-c)based on bone scan, CT scan, or MRI scan.
Demonstrated evidence of progressive disease despite androgen deprivation (androgen
ablation or surgical castration), anti-androgen withdrawal and progression of disease
after docetaxel-based therapy.
2. Demonstrated evidence of progressive disease despite androgen deprivation (androgen
ablation or surgical castration), anti-androgen withdrawal and progression of disease
after docetaxel-based therapy.
• Greater than 25% increase in 3 consecutive tests (PSA 1 < PSA 2 < PSA 3),
each PSA value separated by at least 1 week
3. Serum testosterone level = 50 ng/dL post orchiectomy or while maintained on
continuous or intermittent medical androgen suppression with a LHRH agonist or
antagonist.
4. At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide;
and at least 6 weeks since prior bicalutamide or nilutamide.
5. Systemic corticosteroids discontinued within two weeks of dosing, except low dose
regimens which may continue if unchanged
6. Strontium-89 or Samarium-153 must have been completed at least 8 weeks prior to the
first dose of therapy and recovered from all treatment-related toxicities.
Exclusion Criteria:
1. Must not be receiving concurrent anti-androgen hormonal therapy for hormone
refractory prostate cancer.
Non-Hodgkin's Lymphoma
Inclusion Criteria:
1. Histologically proven relapsed or refractory
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What will happen
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Drug; SGI-1776; Starting dose 100 mg (total daily dose) administer as 50 mg every 12 hours for 14 days of a 21-day cycle, dose escalation in successive cohorts until progression or toxicity develops
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Primary aim
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MTD & DLT
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Secondary Aim
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Response rate, pharmacokinetics, PSA response, renal elimination and pharmacodynamic effects on biomarker modulation.; July 2011; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Stopped
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Nation
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England
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Location
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Sutton
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