NCT01313559

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2012

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

January 16, 2018

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

March 10, 2011

Results QC Date

September 8, 2016

Last Update Submit

April 28, 2025

Conditions

Castrate Resistant Prostate CancerChemotherapy Naive Prostate CancerProstate Cancer

Keywords

Castrate ResistantChemotherapy NaiveProstate CancerSOM230Everolimus

Outcome Measures

Primary Outcomes (1)

  • Number of Participants 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.

    12 weeks after treatment

Secondary Outcomes (3)

  • Number of Participants With > 50% Decline From Baseline PSA Level

    After 12 weeks of treatment

  • Number of Participants Without New Bone Lesions After 12 Weeks of Treatment

    After 12 weeks of treatment

  • Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria

    Assessed up to 30 days after completion of study treatment

Study Arms (2)

Cohort A (pasireotide)

ACTIVE COMPARATOR

Patients receive pasireotide IM once every 4 weeks

Drug: PasireotideOther: Laboratory biomarker analysis

Cohort B (pasireotide and everolimus)

EXPERIMENTAL

Patients receive pasireotide as in cohort A and everolimus PO QD

Drug: PasireotideDrug: EverolimusOther: Laboratory biomarker analysis

Interventions

PasireotideDRUG

Given IM

Also known as: SOM230
Cohort A (pasireotide)Cohort B (pasireotide and everolimus)
EverolimusDRUG

Given PO

Also known as: 42-O-(2-hydroxy)ethyl rapamycin, Afinitor, RAD001
Cohort B (pasireotide and everolimus)
Laboratory biomarker analysisOTHER

Correlative studies

Cohort A (pasireotide)Cohort B (pasireotide and everolimus)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pasireotideEverolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Limitations and Caveats

Study terminated prematurely due to slow accrual

Results Point of Contact

Title
Jianqing Lin, MD
Organization
Thomas Jefferson University
Jianqing.Lin@jefferson.edu
215-955-8874

Study Officials

  • Jianqing Lin, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 11, 2011

Study Start

June 1, 2011

Primary Completion

September 15, 2012

Study Completion

November 29, 2012

Last Updated

April 30, 2025

Results First Posted

January 16, 2018

Record last verified: 2025-04

Locations

US(2)