Skip to main content

Table 3 Key patient selection criteria

From: Study design and rationale for a randomised, placebo-controlled, double-blind study to assess the efficacy of selumetinib (AZD6244; ARRY-142886) in combination with dacarbazine in patients with metastatic uveal melanoma (SUMIT)

Inclusion criteria Exclusion criteria
• Clinical diagnosis of metastatic uveal melanoma • Any prior systemic anticancer therapy, including for the treatment of this current diagnosis
• Histological or cytological confirmation of melanoma • An investigational drug within 30 days of starting treatment, or has not recovered from side effects of an investigational drug
• Male or female aged ≥18 years
• Suitable for treatment with dacarbazine chemotherapy • Any non-systemic anticancer therapy that has not been cleared from the body by the time of starting study treatment
• ≥1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter, which is suitable for accurate repeated measurements
• Radiation therapy within 4 weeks prior to starting study treatment
• Major surgery within 4 weeks prior to entry into the study that would prevent administration of study treatment
• ECOG performance status 0–1
• Life expectancy >12 weeks
• Normal organ and marrow function • Any prior investigational therapy comprising inhibitors of RAS, RAF or MEK at any time
• Negative urinary or serum pregnancy test for women with childbearing potential
• Previous treatment with dacarbazine
• Able to swallow selumetinib/placebo capsules • Any unresolved toxicity > CTCAE grade 2 from previous anticancer therapy, excluding alopecia
• Signed informed consent document
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine
• Symptomatic brain metastases or spinal cord compression
• Cardiac conditions, such as uncontrolled hypertension, acute coronary syndrome, uncontrolled angina or heart failure
• Severe concomitant systemic disorder, active infection, active bleeding diatheses or renal transplant
• Refractory nausea and vomiting, chronic gastrointestinal diseases or significant bowel resection that would preclude adequate absorption
• History of another primary malignancy within 5 years prior to starting study treatment
• Current or past history of retinal pigmented epithelial detachment/central serous retinopathy; retinal vein occlusion; intraocular pressure >21 mmHg; uncontrolled glaucoma
• Female patients who are breast-feeding and male or female patients of reproductive potential who are not employing an effective method of birth control
• Judgement by the investigator that the patient should not participate in the study
  1. CTCAE Common Terminology Criteria for Adverse Events, ECOG Eastern Cooperative Oncology Group