A randomised phase II study of sunitinib versus dacarbazine in the treatment of patients with metastatic uveal melanoma - SUAVE - Sunitinib versus dacarbazine in metastatic uveal melanoma
- Conditions
- Metastatic Uveal MelanomaMedDRA version: 14.1 Level: PT Classification code 10025654 Term: Malignant melanoma of sites other than skin System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2008-008794-55-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
•Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
•Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent
•Patients who have not received any prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
•Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
•Patients with a life expectancy > 12 weeks
•Patients who have ECOG Performance status 0, 1 or 2 (for ECOG scale of performance (see Appendix B)
•Patient has at least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours - RECIST version 1.1 (see Appendix C - contrast enhancing lesion with the largest diameter >10mm, based on spiral CT scan or MRI) done within 28 days of randomisation)
•Patient is aged > 18 years
•Patient has adequate haematological, renal and liver function as defined below and performed within 7 days of randomisation:
oHb > 10 g/dl, platelets > 100x109/L, WCC > 3.0 x109/L, ANC > 1.0x109/L
oBili < 1.5 x ULN, Alk phos < 5 x ULN, AST and ALT < 5 x ULN
oCr < 1.5 x ULN
•Patient has provided written informed consent
•Females of child-bearing potential who have a negative pregnancy test prior to study entry and be using adequate contraception, which they agree to continue for 12 months after the study treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Patients who have:
•Conjunctival melanoma
•Received any previous systemic therapy for metastatic uveal melanoma
•Known leptomeningeal or brain metastases
•Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days respectively, prior to study treatment administration
•Concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed)
•Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections.
•Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
•Clinically significant abnormal cardiac function with abnormal 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater, poorly controlled atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
•Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
•Any medical or psychiatric condition which would influence the ability to provide informed consent
•Pregnant or lactating women
•Lack of informed consent
•Any previous investigational agent within the last 12 weeks
•Pregnant or lactating females
•Patients who have not provided informed consent
•Any medical or psychiatric condition which would influence the ability to provide informed consent
•Patients with a history of prior malignant disease (unless they have had more than 3 years free of disease or have had adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method