Number of Participants Alive and Progression Free After 12 Weeks of Treatment
| Group | Value (participants) |
|---|---|
| Cohort A (Pasireotide) | 0 |
| Cohort B (Pasireotide and Everolimus) | 0 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Slow accrual
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
NCT01313559Jun 2011 to 29 Nov 2012
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).
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
Outcomes the sponsor listed as primary.
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
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Cohort A (Pasireotide) | 0 |
| Cohort B (Pasireotide and Everolimus) | 0 |
| Group | Value (participants) |
|---|---|
| Cohort A (Pasireotide) | 2 |
| Cohort B (Pasireotide and Everolimus) | 0 |
| Group | Value (participants) |
|---|---|
| Cohort A (Pasireotide) | 0 |
| Cohort B (Pasireotide and Everolimus) | 0 |
| Group | Value (participants) |
|---|---|
| Cohort A (Pasireotide) | 0 |
| Cohort B (Pasireotide and Everolimus) | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cohort A (Pasireotide)Patients receive pasireotide IM once every 4 weeks Pasireotide: Given IM Laboratory biomarker analysis: Correlative studies | – | 1 / 4 | 4 / 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 / 2 | 2 / 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
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