Metastatic Uveal Melanoma MedDRA 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)
Conditions
Interventions
Trade Name: Sutent
Product Name: Sunitinib
Product Code: SU011248
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib Mala
Sponsors
The Clatterbridge Cancer Centre NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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: o Hb > 10 g/dl, platelets > 100x109/L, WCC > 3.0 x109/L, ANC > 1.0x109/L o Bili =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can the progression free survival time of patients with metastatic Uveal Melanoma be extended by treatment with Sunitinib, compared with the treatment by Dacarbazine?; Secondary Objective: -What is the overall survival time of the patients participating in the clinical trial? - What is the overall response rate of the patients to their allocated study treatment? -Do either of the treatments cause any adverse events? -How long is time to progression on first-line treatment? -How long is time to progression on second line treatment (for patients who receive cross-over therapy) -What is the overall response rate on first-line treatment compared to overall response rate on second-line treatment (for patients who receive cross-over therapy) -Can certain molecules in the blood help to determine how a patient will do after diagnosis and how they will respond to treatment -How difficult is it to recruit patients with metastatic uveal melanoma to a clinical trial? ; Primary end point(s): The primary outcome measure for this trial is the progression-free survival time measured from date of randomisation. For patients with evidence of progressive disease (as measured by CT scan, or MRI if necessary) or patients who have died from any cause, progression-free survival time will be calculated to date of progressive disease or date of death (whichever occurs first) and will be counted as events in the analysis. Patients still alive with no evidence of progression at the time of their last visit are censored at the time of the most recent information. Analysis will take place once all patients have been followed up for at least 3 months. | — |
Countries
United Kingdom
Outcome results
None listed