Status:
TERMINATED
Safety of SGI-1776, A PIM Kinase Inhibitor in Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma
Lead Sponsor:
Astex Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 av...
Eligibility Criteria
Inclusion
- General
- Read, understand and sign the IRB- or IEC-approved ICF confirming his or her willingness to participate in this trial.
- At least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.
- 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
- Active secondary malignancy or history of other malignancy within the last two years except non-melanoma skin cancers or cervical carcinoma in situ.
- 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.
- 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.
- Received prior radiation therapy within the past 4 weeks or received irradiation of ≥ 25% of their bone marrow reserve.
- Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
- Symptomatic CNS metastases or lesions for which treatment is required.
- Prostate Cancer
- Inclusion Criteria:
- 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.
- 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
- Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.
- At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide; and at least 6 weeks since prior bicalutamide or nilutamide.
- Systemic corticosteroids discontinued within two weeks of dosing, except low dose regimens which may continue if unchanged
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00848601
Start Date
February 1 2009
End Date
October 1 2010
Last Update
August 2 2024
Active Locations (3)
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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