Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01313559|
Recruitment Status : Terminated (Slow accrual)
First Posted : March 11, 2011
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Castrate Resistant Prostate Cancer Chemotherapy Naive Prostate Cancer Prostate Cancer||Drug: Pasireotide Drug: Everolimus Other: Laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Randomized Phase II Study of SOM230 and Everolimus in Castrate-Resistant, Chemotherapy-Naïve Prostate Cancer Patients|
|Study Start Date :||June 2011|
|Primary Completion Date :||September 15, 2012|
|Study Completion Date :||November 29, 2012|
Active Comparator: Cohort A (pasireotide)
Patients receive pasireotide IM once every 4 weeks
Other Name: SOM230Other: Laboratory biomarker analysis
Experimental: Cohort B (pasireotide and everolimus)
Patients receive pasireotide as in cohort A and everolimus PO QD
Other Name: SOM230Drug: Everolimus
Other Names:Other: Laboratory biomarker analysis
- Number of Participants Alive and Progression Free After 12 Weeks of Treatment [ Time Frame: 12 weeks after 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.
- Number of Participants With > 50% Decline From Baseline PSA Level [ Time Frame: After 12 weeks of treatment ]
- Number of Participants Without New Bone Lesions After 12 Weeks of Treatment [ Time Frame: After 12 weeks of treatment ]
- Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria [ Time Frame: Assessed up to 30 days after completion of study treatment ]Progression free survival (PFS) based on primary outcome criteria for disease progression. Patients without radiographic disease progression who permanently discontinue the study drugs will be censored
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|
|Principal Investigator:||Jianqing Lin, MD||Thomas Jefferson University|