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An Open Label Randomized Phase II Study of SOM230 and Everolimus in Castrate-Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Phase 2
18 Years
Open (Enrolling)
Castrate Resistant Prostate Cancer, Chemotherapy Naive Prostate Cancer, Prostate Cancer

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Trial Information

An Open Label Randomized Phase II Study of SOM230 and Everolimus in Castrate-Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Prostate cancer cells typically have neuroendocrine (NE) differentiation features after they
become resistant to hormonal therapy. Somatostatin (SST - a peptide hormone) receptors
(SSTR) are usually expressed in a high level in these advanced prostate cancer cells. When
SSTR is activated pharmacologically by drugs similar to SST, prostate cancer cell growth is
inhibited. SOM230 is a new agent which can activate SSTR and block other key survival
molecules/pathways such as phosphatidylinositol 3-kinases (PI3K), mitogen-activated protein
(MAP) kinases (MAPK) signaling pathways. Thus SOM230 itself has anticancer activity for
prostate cancer.

It is also well known that hormonal refractory prostate cancer can grow in an environment of
very low male hormone level because of the activation of several non-androgen receptor
survival pathways. One key survival pathway is mediated by an important molecule called
mammalian target of rapamycin (mTOR). Drugs, such as Everolimus, have anticancer activity
in prostate cancer pre-clinically, but do not sustain its activity. The reason was that
cancer cells can up-regulate other survival pathways such as PI3K, MAPK, thus bypass mTOR.

It is hypothesized that SOM230 not only have anti-tumor effect in prostate cancer directly,
but also can block the up-regulated (feed-back loop), alternative PI3K or MAPK survival
pathways induced by mTOR inhibitors.

The goal of this study is to develop a new well tolerated therapy that can be offered to
prostate cancer patients prior to receiving chemotherapy.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression of Disease

Outcome Description:

Progression of disease is defined as disease progression by RECIST 1.1 criteria on CT scan (X-ray computed tomography), or appearance of > 2 new bone lesions on bone scan, or prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria or death from any cause.

Outcome Time Frame:

Proportion of patients alive and progression free after 12 weeks of treatment

Safety Issue:


Principal Investigator

Jianqing Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

June 2016

Related Keywords:

  • Castrate Resistant Prostate Cancer
  • Chemotherapy Naive Prostate Cancer
  • Prostate Cancer
  • Castrate Resistant
  • Chemotherapy Naive
  • Prostate Cancer
  • SOM230
  • Everolimus
  • Prostatic Neoplasms



Yale Cancer CenterNew Haven, Connecticut  06520-8028
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541