Safety of SGI-1776, A PIM Kinase Inhibitor in Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- MTD & DLT [July 2011]
Secondary Outcome Measures
- Response rate, pharmacokinetics, PSA response, renal elimination and pharmacodynamic effects on biomarker modulation. [July 2011]
Eligibility Criteria
Criteria
General
Inclusion Criteria:
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Read, understand and sign the IRB- or IEC-approved ICF confirming his or her willingness to participate in this trial.
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At least 18 years old.
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
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Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.
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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:
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Active secondary malignancy or history of other malignancy within the last two years except non-melanoma skin cancers or cervical carcinoma in situ.
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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.
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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.
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Received prior radiation therapy within the past 4 weeks or received irradiation of ≥ 25% of their bone marrow reserve.
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Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
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Symptomatic CNS metastases or lesions for which treatment is required.
Prostate Cancer
Inclusion Criteria:
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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.
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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
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Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.
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At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide; and at least 6 weeks since prior bicalutamide or nilutamide.
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Systemic corticosteroids discontinued within two weeks of dosing, except low dose regimens which may continue if unchanged
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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:
- Must not be receiving concurrent anti-androgen hormonal therapy for hormone refractory prostate cancer.
Non-Hodgkin's Lymphoma
Inclusion Criteria:
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Histologically proven relapsed or refractory non-Hodgkin's lymphoma subjects for which there is no available standard therapy or therapy which may provide clinical benefit.
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Measurable disease (at least 1 lesion ≥ 1.5 cm).
Exclusion Criteria:
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Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter.
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Systemic corticosteroids within 2 weeks, except low dose regimens which may continue if unchanged.
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Received any radiopharmaceutical therapy within the past six weeks.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | UCLA | Los Angeles | California | United States | 90095-1678 |
2 | Cancer Therapy Research Center | San Antonio | Texas | United States | 78229 |
3 | Royal Marsden Hospital | Sutton | England | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Astex Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGI-1776-01