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Study ID
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11D.78
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Investigator
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Jianqing Lin, MD, Thomas Jefferson University
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Title
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Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
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Conditions
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Castrate Resistant Prostate Cancer
Chemotherapy Naive Prostate Cancer
Prostate Cancer
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Interventions
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Drug: Pasireotide
Drug: Everolimus
Other: Laboratory biomarker analysis
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Phase
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Phase 2
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Purpose
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This is an open label randomized phase II study for prostate cancer patients who have
disease progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor
of prostate cancer cells and can prevent them from growing. Everolimus works by targeting a
cell survival factor in prostate cancer. The combination of these drugs may work better for
the treatment of prostate cancer without toxic chemotherapy. Patients will receive either
SOM230 LAR (group A) or SOM230 LAR in combination with Everolimus (group B).
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Eligibility
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Ages Eligible: 18 Years
Genders Eligible:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:- Age minimum: 18 years old
- Histological confirmation of prostatic adenocarcinoma
- PSA > or = to 2 ng/ml
- PSA progression (serially rises on two occasions each at least one week apart) OR
disease progression on imaging studies (CT scan or bone scan).
- Minimally symptomatic - no symptoms attributed to prostate cancer greater than Grade
I based on NCI CTCAE Version 4.0 grading of toxicities
- Discontinuation of all antiandrogen, ketoconazole and investigational drugs for at
least 4 weeks (6 weeks for bicalutamide) prior to study initiation
- Maintain castrate levels of testosterone (<50ng/dL)
- Karnofsky Performance Status > or = to 60%
- Life expectancy > 3 months
- Adequate hematologic, renal, and liver function
Exclusion Criteria:- Currently active second malignancy other than non-melanoma skin cancers.
- Clinically significant cardiovascular disease: EF < 30%, NHYA Class III or greater
congestive heart failure, myocardial infarction/unstable angina within 6 months prior
to study enrollment, or significant ECG abnormalities such as QRS/QT prolongation
(see Section 5.3).
- Progressive pulmonary disease, such as advanced COPD, pulmonary fibrosis, or
supplemental O2 requirement.
- Known CNS disease, except for treated brain metastases.
- Poorly controlled diabetes mellitus (HbA1c > 7 %) or fasting blood glucose level >126
mg/dL in non-diabetic patients or > 189 mg/dL in diabetic patients (can be enrolled
after initiation or titration of anti-diabetic agent(s)).
- Poorly controlled hypercholesterolemia (fasting serum cholesterol >300 mg/dL) or
hypertriglyceridemia (> 2.5 x ULN). Patients above either threshold can be included
after initiation of appropriate lipid lowering medication.
- Current use of chronic steroids (equivalent of 20mg prednisone daily). Inhaled
steroids are acceptable.
- Active gallbladder disease or hepatitis (AST or ALT > 2.0, or bilirubin > 1.5x ULN),
liver cirrhosis, or severe liver impairment (Child-Pugh class C). It is highly
recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically
with an antiviral for 1-2 weeks prior to receiving study drug.
- Serum creatinine >1.5 upper limit of normal or on dialysis.
- Prior use of a somatostatin analog or mTOR inhibitor for the treatment of PC.
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Study Location
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N/A
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Contact
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Jianqing Lin, MD
215-955-8874
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Information obtained from ClinicalTrials.gov, on
6/18/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01313559
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