Trial Outcomes & Findings for RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma (NCT NCT01252251)
NCT ID: NCT01252251
Last Updated: 2017-08-01
Results Overview
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
at 16 weeks
Results posted on
2017-08-01
Participant Flow
Protocol Open to Accrual 11/30/2010, Protocol Closed to Accrual 8/11/2015, Primary Completion Date 6/13/2016, Recruitment location is the medical clinic
Participant milestones
| Measure |
RAD001 and Pasireotide LAR
This 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.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RAD001 and Pasireotide LAR
This 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.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma
Baseline characteristics by cohort
| Measure |
RAD001 and Pasireotide LAR
n=14 Participants
This 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.
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|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at 16 weeksFor patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Outcome measures
| Measure |
RAD001 and Pasireotide LAR
n=13 Participants
This 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.
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|---|---|
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Number of Participants With Complete Response (CR)
Participants Evaluated
|
13 Participants
|
|
Number of Participants With Complete Response (CR)
Complete Response
|
0 Participants
|
PRIMARY outcome
Timeframe: at 16 weeksFor patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Outcome measures
| Measure |
RAD001 and Pasireotide LAR
n=13 Participants
This 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.
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|---|---|
|
Number of Participants With Partial Response (PR)
Partial Response
|
0 Participants
|
|
Number of Participants With Partial Response (PR)
Participants Evaluated
|
13 Participants
|
PRIMARY outcome
Timeframe: at 16 weeksFor patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Outcome measures
| Measure |
RAD001 and Pasireotide LAR
n=13 Participants
This 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.
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|---|---|
|
Number of Participants With Stable Disease (SD)
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
RAD001 and Pasireotide LAR
n=13 Participants
This 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.
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|---|---|
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Median Progression Free Survival(PFS)
|
16 weeks
Interval 7.0 to 23.0
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SECONDARY outcome
Timeframe: 16 weeksSafety 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,
Outcome measures
| Measure |
RAD001 and Pasireotide LAR
n=13 Participants
This 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.
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|---|---|
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Safety and Toxicity in This Patient Population.
At least 1 dose reduction due to toxicity
|
7 Participants
|
|
Safety and Toxicity in This Patient Population.
No dose reduction due to toxicity
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
RAD001 and Pasireotide LAR
n=13 Participants
This 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.
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|---|---|
|
Median Overall Survival (OS)
|
11 months
Interval 4.5 to 28.5
|
Adverse Events
RAD001 and Pasireotide LAR
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001 and Pasireotide LAR
n=13 participants at risk
This 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.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • 28 weeks
|
|
Hepatobiliary disorders
Acute kidney injury
|
15.4%
2/13 • 28 weeks
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • 28 weeks
|
|
General disorders
Fatigue
|
7.7%
1/13 • 28 weeks
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • 28 weeks
|
Other adverse events
| Measure |
RAD001 and Pasireotide LAR
n=13 participants at risk
This 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.
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|---|---|
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Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
13/13 • 28 weeks
|
|
Investigations
Cholesterol high
|
84.6%
11/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
84.6%
11/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
69.2%
9/13 • 28 weeks
|
|
Investigations
White blood cell decreased
|
69.2%
9/13 • 28 weeks
|
|
Investigations
CPK increased
|
61.5%
8/13 • 28 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
61.5%
8/13 • 28 weeks
|
|
Investigations
Platelet count decreased
|
61.5%
8/13 • 28 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
53.8%
7/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
46.2%
6/13 • 28 weeks
|
|
Investigations
Alkaline phosphatase increased
|
38.5%
5/13 • 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • 28 weeks
|
|
Investigations
Neutrophil count decreased
|
38.5%
5/13 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • 28 weeks
|
|
General disorders
Fatigue
|
30.8%
4/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.8%
4/13 • 28 weeks
|
|
Investigations
Alanine aminotransferase increased
|
23.1%
3/13 • 28 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
3/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • 28 weeks
|
|
Investigations
Serum amylase increased
|
23.1%
3/13 • 28 weeks
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • 28 weeks
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
2/13 • 28 weeks
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
2/13 • 28 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.4%
2/13 • 28 weeks
|
|
Investigations
Lipase increased
|
15.4%
2/13 • 28 weeks
|
|
General disorders
Non-cardiac chest pain
|
15.4%
2/13 • 28 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Anal mucositis
|
7.7%
1/13 • 28 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • 28 weeks
|
|
Eye disorders
Blurred vision
|
7.7%
1/13 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • 28 weeks
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.7%
1/13 • 28 weeks
|
|
General disorders
Fever
|
7.7%
1/13 • 28 weeks
|
|
Vascular disorders
Hot flashes
|
7.7%
1/13 • 28 weeks
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • 28 weeks
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.7%
1/13 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
1/13 • 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • 28 weeks
|
Additional Information
Dr. Michael Postow, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4589
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place