A Randomized Discontinuation, Blinded, Placebo-Controlled, Phase II Study of Sorafenib in Patients with Chemonaïve Metastatic Uveal Melanoma(Sorafenib Treatment of Metastatic Uveal Melanoma)

Phase 1

• Conditions: choroid melanoma; MedDRA version: 16.1Level: PTClassification code 10008773Term: Choroid melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-022687-12-DE
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-14
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 (histological or cytological confirmation in case of only extrahepatic metastasis not required for inclusion)
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, 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 (if liver metastases = 5 x ULN)
Alanine aminotransferase (ALT) = 2.5 x ULN (if liver metastases = 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 (combined oral contraceptives, hormone-releasing intrauterine contraceptive device, hormonal contraceptive implants, hormonal contraceptive injectables) in combination with barrier birth control measures during the course of the trial
or be surgically sterile
A female subject is considered to be of childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2 year, or unless she is surgically sterile.
12. Males must agree to use barrier birth control measures (condomes) during the course of the trial. In addition males must agree to continue to use these barrier birth control measures for at least 3 months after last administration of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous or concurrent tumor other than uveal melanoma with the exception of cervical cancer in situ, adaequately 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 = New York Heart Association (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. Known HIV infection
4. Known chronic infection with hepatitis B or C
5. Active infection requiring systemic antibiotic/antiviral/antifungal treatment or any uncontrolled infection > Grade 2 NCI-CTCAE
6. 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)
7. Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
8. History of organ allograft
9. Patients with evidence or history of bleeding diathesis
10. Thrombotic or embolic events within the last 6 months
11. Serious non-healing wound, ulcer or fracture
12. 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
13. Pregnant or breast-feeding patients
14. Marked claustrophobia
15. Cardiac pacemaker, cochlea implants or other implanted metal devices, residual metal splinters
16. Known allergy to the used study drug sorafenib or to any of its excipients
17. Known hypersensitivity to gadolinium based contrast agents
18. Subject unwilling or unable to comply with study requirements
19. Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results
20. 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
21. Patients receiving anticoagulation therapy with warfarin or phenprocoumon
22. Treatment with any of the following therapies or drugs
- Any prior palliative chemotherapy, tyrosine kinase inhibitors (TKI´s) or antiangiogenics (prior adjuvant treatment with vaccine or immunotherapy is allowed provided there is documentation of disease progression).
- Any chemotherapy, hormonal therapy, immunotherapy, targeted therapy or experimental or approved proteins/antibodies within four weeks prior to study enrollment or during study participation.
- Radiotherapy or brachytherapy within four weeks prior to study enrollment or during study participation except to eye or bone.
- Hepatic chemoembolization within four weeks prior to study enrollment or during study participation:
- Major surgery within 4 weeks of study enrollment
- Autologous bone marrow transplant or stem cell rescue within 4 months of study enrollment
- Use of biologic response modifiers, such as G-CSF, within 3 week of study enrollment. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however, they may not be substituted for a required dose reduction.)
- Patie

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified