Number of Participants With Complete Response (CR)
| Group | Value (Participants) |
|---|---|
| RAD001 and Pasireotide LAR | 13 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma
NCT01252251Nov 2010 to Jun 2016
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230. Pasireotide is an experimental drug and is not approved by the Food and Drug Administration. Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney cancer. Everolimus is not approved for treatment of melanomas, but early studies show that it may help some patients with melanoma.
Experimental
RAD001 and pasireotide LAR
This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
Outcomes the sponsor listed as primary.
Number of Participants With Complete Response (CR)
Time frame · at 16 weeks
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Number of Participants With Partial Response (PR)
Time frame · at 16 weeks
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Number of Participants With Stable Disease (SD)
Time frame · at 16 weeks
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Median Progression Free Survival(PFS)
Time frame · Up to 3 years
Safety and Toxicity in This Patient Population.
Time frame · 16 weeks
Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, the regular monitoring of hematology (including glycosylated hemoglobin and coagulation parameters), blood chemistry (including fasting glucose, thyroid function tests, GH, IGF-1 and prolactin), urinalysis, regular monitoring of vital signs, echocardiography, ECGs, and body weight. Toxicity will be assessed using the NCI-CTC for Adverse Events, version 4.0 (CTCAEv4.0,
Median Overall Survival (OS)
Time frame · Up to 3 years
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| RAD001 and Pasireotide LAR | 13 |
| Group | Value (Participants) |
|---|---|
| RAD001 and Pasireotide LAR | 13 |
| Group | Value (Participants) |
|---|---|
| RAD001 and Pasireotide LAR | 7 |
| Group | Value (weeks) |
|---|---|
| RAD001 and Pasireotide LAR | 16 |
| Group | Value (Participants) |
|---|---|
| RAD001 and Pasireotide LAR | 7 |
| Group | Value (months) |
|---|---|
| RAD001 and Pasireotide LAR | 11 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| RAD001 and Pasireotide LARThis study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR. RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42. | 0 / 13 | 6 / 13 | 13 / 13 |
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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