A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01377025
• Date of registration: 14/06/2011
• Primary sponsor: University Hospital, Essen
• Public title: A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma STREAM
• Scientific title: A Randomized Discontinuation, Blinded, Placebo-Controlled Phase II Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma
• Date of first enrolment: June 2011
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01377025
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Max El Scheulen, Prof.

• Name: Max E. Scheulen, Prof.
• Affiliation: Universiätsklinikum Essen

Key inclusion & exclusion criteria

Inclusion criteria:

1. Signed and dated written informed consent before the start of specific protocol
procedures

2. Metastatic uveal melanoma with histological or cytological confirmation of liver
metastasis

3. By means of whole body MRI documented disease according to RECIST version 1.1 with at
least one unidimensional measurable lesion = 10 mm

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

5. Male or female patients = 18 years of age

6. Estimated life-expectancy more than 5 months

7. Hematologic function, as follows:

- Absolute neutrophil count (ANC) = 1.5 x 109/L

- Platelet count = 100 x 109/L

- Hemoglobin = 9 g/dL

8. Renal function, as follows

-Creatinine = 1.5 x upper limit of normal (ULN)

9. Hepatic function, as follows

- Aspartate aminotransferase (AST) = 2.5 x ULN

- Alanine aminotransferase (ALT) = 2.5 x ULN

- Total bilirubin = 3 mg/dl

- Alkaline phosphatase = 4.0 x ULN

10. PT-INR/PT < 1.5 x ULN

11. Females of childbearing potential (FCBP) must have a negative pregnancy test within
7 days of the first application of study treatment and must agree to use effective
contraceptive birth control measures

12. Males must agree to use barrier birth control measures (condoms) during the course of
the trial.

Exclusion criteria:

1. Previous or concurrent tumor other than uveal melanoma with the exception of cervical
cancer in situ, adequately treated basal cell carcinoma, superficial bladder tumors
(Ta, Tis, and T1) or any curatively treated tumors > 3 years prior to enrollment

2. History of cardiac disease: congestive heart failure = NYHA class 2; active coronary
artery disease ([CAD], myocardial infarction more than 6 months prior to study entry
is allowed), cardiac arrhythmias requiring antiarrhythmic therapy (only beta blockers
or digoxin are permitted)

3. QT/QTc-interval prolongation (QTc> 450 msec) on ECG, known Long QT syndrome or known
Long QT syndrome in relatives

4. Known HIV infection

5. Known chronic infection with hepatitis B or C

6. Hypokalemia, hypocalcemia, hypomagnesemia or patients under actual treatment against
hypokalemia, hypocalcemia, hypomagnesemia

7. Active infection requiring systemic antibiotic/antiviral/antifungal treatment or any
uncontrolled infection > Grade 2 NCI-CTCAE

8. Symptomatic brain or meningeal tumors (unless patient is > 6 months from definitive
therapy, had a negative imaging study within 4 weeks of study entry and is clinically
stable with respect to the tumor at the time of study enrollment)

9. Patients with seizure disorder requiring medication (such as steroids or
antiepileptics)

10. History of organ allograft

11. Patients with evidence or history of bleeding diathesis

12. Thrombotic or embolic events within the last 6 months

13. Serious non-healing wound, ulcer or fracture

14. Uncontrolled arterial hypertension with systolic blood pressure >150 mm Hg and/ or
diastolic blood pressure > 90 mg Hg despite optimal treatment, determined twice
within one week

15. Pregnant or breast-feeding patients

16. Marked claustrophobia

17. Cardiac pacemaker, cochlea implants or other implanted metal devices, residual metal
splinters

18. Known allergy to the used study drug sorafenib or to any of its excipients

19. Known hypersensitivity to gadolinium based contrast agents

20. Subject unwilling or unable to comply with study requirements

21. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

22. Participation in any clinical study or treatment with an experimental drug or
experimental therapy within 28 days prior to study enrollment or during study
participation



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Uveal Melanoma

Intervention(s)

Drug: Placebo

Drug: Sorafenib

Primary Outcome(s)

Progression Free Survival [Time Frame: Every 8 weeks for 1 year]

Secondary Outcome(s)

Number of patients with adverse events [Time Frame: Every 8 weeks for 1 year]

Overall Survival [Time Frame: Every 8 weeks for 2 years]

Secondary ID(s)

2010-022687-12

STREAM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors