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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT01313559 (opens ClinicalTrials.gov in a new tab)Other id11D.78Other id2010-52Other idJT 2184

Overview

Status
Terminated
Phase
Phase 2
Enrollment
6 participants (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2011
Primary completion
15 Sept 2012
Completion
29 Nov 2012
First posted
11 Mar 2011 (estimated)
Last update posted
30 Apr 2025
Conditions
Castrate Resistant Prostate Cancer · Chemotherapy Naive Prostate Cancer · Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 2

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

    NCT01313559

    Jun 2011 to 29 Nov 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • PasireotideDrug
  • EverolimusDrug
  • Laboratory biomarker analysisOther

Arms2

  • Active comparator

    Cohort A (pasireotide)

    Patients receive pasireotide IM once every 4 weeks

  • Experimental

    Cohort B (pasireotide and everolimus)

    Patients receive pasireotide as in cohort A and everolimus PO QD

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Alive and Progression Free After 12 Weeks of Treatment

    Time frame · 12 weeks after treatment

    Registry 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.

Secondary outcomes(3)
  1. Number of Participants With > 50% Decline From Baseline PSA Level

    Time frame · After 12 weeks of treatment

  2. Number of Participants Without New Bone Lesions After 12 Weeks of Treatment

    Time frame · After 12 weeks of treatment

  3. 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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 12 weeks after treatment

Number of Participants Alive and Progression Free After 12 Weeks of Treatment

GroupValue (participants)
Cohort A (Pasireotide)0
Cohort B (Pasireotide and Everolimus)0
Secondary and other outcome results(3)
Secondary outcomeNumber· After 12 weeks of treatment

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

GroupValue (participants)
Cohort A (Pasireotide)2
Cohort B (Pasireotide and Everolimus)0
Secondary outcomeNumber· After 12 weeks of treatment

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

GroupValue (participants)
Cohort A (Pasireotide)0
Cohort B (Pasireotide and Everolimus)0
Secondary outcomeNumber· Assessed up to 30 days after completion of study treatment

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

GroupValue (participants)
Cohort A (Pasireotide)0
Cohort B (Pasireotide and Everolimus)0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cohort A (Pasireotide)Patients receive pasireotide IM once every 4 weeks Pasireotide: Given IM Laboratory biomarker analysis: Correlative studies–1 / 44 / 4
Cohort B (Pasireotide and Everolimus)Patients receive pasireotide as in cohort A and everolimus PO QD Pasireotide: Given IM Everolimus: Given PO Laboratory biomarker analysis: Correlative studies–0 / 22 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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