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Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer

This study has been terminated.
ClinicalTrials.gov Identifier:
First Posted: March 11, 2011
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Thomas Jefferson University
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).

Condition Intervention Phase
Castrate Resistant Prostate Cancer Chemotherapy Naive Prostate Cancer Prostate Cancer Drug: Pasireotide Drug: Everolimus Other: Laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Phase II Study of SOM230 and Everolimus in Castrate-Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Resource links provided by NLM:

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Progression of Disease [ Time Frame: Proportion of patients alive and progression free after 12 weeks of treatment ]
    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.

Secondary Outcome Measures:
  • PSA response rate based on > 50% decline from baseline PSA level [ Time Frame: After 12 weeks of treatment ]
    Will be reported as medians with standard error

  • Radiographic response rate (partial response or complete response by RECIST 1.1 criteria and no new bone metastases on bone scan) [ Time Frame: After 12 weeks of treatment ]
    Reported as medians with standard error

  • Median progression free survival (PFS) based on RECIST 1.1 criteria [ Time Frame: Assessed up to 30 days after completion of study treatment ]
    Reported as medians with standard error. Possible risk factors will be compared for survival with Kaplan-Meier estimates and log-rank tests.

  • Observed toxicities and dose modifications of SOM230 alone and in combination with everolimus assessed using the NCICTCAE version 4.0 grading of toxicities [ Time Frame: Assessed up to 30 days after completion of study treatment ]
    Summarized using exact methods

Estimated Enrollment: 64
Study Start Date: June 2011
Estimated Study Completion Date: June 2018
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort A (pasireotide)
Patients receive pasireotide IM once every 4 weeks
Drug: Pasireotide
Given IM
Other Name: SOM230
Other: Laboratory biomarker analysis
Correlative studies
Experimental: Cohort B (pasireotide and everolimus)
Patients receive pasireotide as in cohort A and everolimus PO QD
Drug: Pasireotide
Given IM
Other Name: SOM230
Drug: Everolimus
Given PO
Other Names:
  • 42-O-(2-hydroxy)ethyl rapamycin
  • Afinitor
  • RAD001
Other: Laboratory biomarker analysis
Correlative studies

Detailed Description:

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313559

United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Novartis Pharmaceuticals
Principal Investigator: Jianqing Lin, MD Thomas Jefferson University
  More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01313559     History of Changes
Other Study ID Numbers: 11D.78
2010-52 ( Other Identifier: CCRRC )
First Submitted: March 10, 2011
First Posted: March 11, 2011
Last Update Posted: December 13, 2017
Last Verified: July 2015

Keywords provided by Thomas Jefferson University:
Castrate Resistant
Chemotherapy Naive
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists