Uveal MelanomaPhase 2NCT01252251
RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma
A Phase 2 study testing RAD001 (Everolimus) and Pasireotide (SOM230) LAR in people with Uveal Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- RAD001 (Everolimus) and Pasireotide (SOM230) LAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed metastatic uveal melanoma.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = to 20 mm with conventional techniques or as > or = to 10 mm with spiral CT scan.
- Patients may have had any number of prior therapies, but cannot have previously been treated with a somatostatin analogue or an mTOR inhibitor. At least 3 weeks must have elapsed since the last dose of systemic therapy. At least 6 weeks must have elapsed if the last regimen included BCNU or mitomycin C. At least 3 months must have elapsed if the last regimen included an anti-CTLA4 antibody. If the last regimen included an anti-CTLA4 antibody, radiographic disease progression since this therapy must be documented.
- Age > or = to 18 years. Because no dosing or adverse event data are currently available on the use of RAD001 and SOM230 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
- Life expectancy of greater than 3 months.
- ECOG performance status 0 or 1.
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- Patients must have normal organ and marrow function as defined below:
- leukocytes > or = to 3,000/mcL
- absolute neutrophil count > or = to 1,500/mcL
- platelets > or = to 100,000/mcL
- hemoglobin > or = to 9.0 g/dL not requiring transfusions within the past 2 weeks
- total bilirubin < 1.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
- Creatinine ≤ 1.5 X institutional upper limit of normal or creatinine clearance less than 60 ml/min
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- INR ≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of study initiation).
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
- Ability to understand and the willingness to sign a written informed consent document.
- Evidence of disease progression, as determined by the investigator.
Who cannot join
- Patients may not be receiving any other investigational agents.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. Treated brain metastases must have been stable for at least 2 months.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 or SOM230.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or bleeding, severely impaired lung function, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because RAD001 and SOM230 are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breast-feeding should be discontinued.
- Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot). The safety of a potentially immunosuppressive drug like everolimus is not proven in patients with HIV. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection (see Section 8.0 and hepatitis B/C risk factor screening form.
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- Baseline QTc > 450 ms.
- Patients with risk factors for torsades de pointes, including uncorrected hypokalemia, uncorrected hypomagnesemia, family history of long QT syndrome, clinically significant/symptomatic bradycardia, high-grade AV block, autonomic neuropathy (including that caused by diabetes or Parkinson's disease, uncontrolled hypothyroidism, cirrhosis, or the use of concomitant medications known to prolong the QT interval.
- Patients with a history of syncope, family history of idiopathic sudden death, a history of sustained or clinically significant cardiac arrhythmias, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, or a history of acute myocardial infarction within the six months preceding enrollment .
- No concomitant anti-cancer chemotherapy or other systemic drugs. Palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria.
- Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
- Chronic treatment with systemic steroids or another immunosuppressive agent.
- Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry. Close contact with those who have received attenuated live vaccines should be avoided during treatment with RAD001. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
- Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.
- Patients with a fasting plasma glucose > 1.5 ULN. Note: At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
- Patients with symptomatic cholelithiasis.
- Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving treatment with pasireotide or RAD001.
- History of liver disease, such as cirrhosis or chronic active hepatitis B and C.
- Presence of Hepatitis B surface antigen (HbsAg).
- Presence of Hepatitis C antibody test (anti-HCV).
- History of, or current alcohol misuse/abuse within the past 12 months.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma
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.
- Conditions
- Uveal Melanoma
- Being tested
- RAD001 (Everolimus) and Pasireotide (SOM230) LAR
- Keywords
- PASIREOTIDE (SOM230), RAD001 (EVEROLIMUS), eye, 10-123
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001 (Everolimus) and Pasireotide (SOM230) LARDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| RAD001 and pasireotide LAR | Experimental | This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR. Receives: Drug: RAD001 (Everolimus) and Pasireotide (SOM230) LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Response (CR)
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Measured: at 16 weeks
Number of Participants With Partial Response (PR)
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Measured: at 16 weeks
Number of Participants With Stable Disease (SD)
For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
Measured: at 16 weeks
Secondary outcomes (3)
Median Progression Free Survival(PFS)
Measured: Up to 3 years
Safety and Toxicity in This Patient Population.
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,
Measured: 16 weeks
Median Overall Survival (OS)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael Postow, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252251
- Sponsor's protocol ID
- 10-123
- Status last verified
- Jun 2016
- First submitted
- 1 Dec 2010
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma
- ClinicalTrials.gov ID
- NCT01252251
- Acronym / sponsor ID
- 10-123
- Conditions
- Uveal Melanoma
- Keywords
- PASIREOTIDE (SOM230), RAD001 (EVEROLIMUS), eye, 10-123
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Nov 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 and pasireotide LAR | Experimental | Drug: RAD001 (Everolimus) and Pasireotide (SOM230) LARThis study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have histologically or cytologically confirmed metastatic uveal melanoma.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = to 20 mm with conventional techniques or as > or = to 10 mm with spiral CT scan.
- Patients may have had any number of prior therapies, but cannot have previously been treated with a somatostatin analogue or an mTOR inhibitor. At least 3 weeks must have elapsed since the last dose of systemic therapy. At least 6 weeks must have elapsed if the last regimen included BCNU or mitomycin C. At least 3 months must have elapsed if the last regimen included an anti-CTLA4 antibody. If the last regimen included an anti-CTLA4 antibody, radiographic disease progression since this therapy must be documented.
- Age > or = to 18 years. Because no dosing or adverse event data are currently available on the use of RAD001 and SOM230 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
- Life expectancy of greater than 3 months.
Key exclusion criteria (22 listed)
- Patients may not be receiving any other investigational agents.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. Treated brain metastases must have been stable for at least 2 months.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 or SOM230.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or bleeding, severely impaired lung function, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because RAD001 and SOM230 are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breast-feeding should be discontinued.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001 (Everolimus) and Pasireotide (SOM230) LARPatients 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. | Drug | RAD001 and pasireotide LAR |
Primary outcome
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.
3 secondary outcomes
Median Progression Free Survival(PFS)
Time frame: Up to 3 years
Safety and Toxicity in This Patient Population.
Time frame: 16 weeks
Median Overall Survival (OS)
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Postow, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD001 (Everolimus) and Pasireotide (SOM230) LAR in people with Uveal Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Response (CR) (time frame: at 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.