Any current brain or subdural metastases Patients with active brain or subdural metastases are not eligible, unless they have completed local (radiation) therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least weeks before starting study treatment; any symptoms attributed to brain metastases will be stable for at least weeks before starting study treatment Participants with brain or subdural metastases are not eligible unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy and have discontinued the use of corticosteroids for this indication for at least days prior to study drug administration. Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids, anti-convulsants or have been on stable dose of corticosteroids for at least weeks before starting study treatment; any symptoms attributed to brain metastases must be stable for at least weeks before starting study treatment Presence of brain or subdural metastases Any history of or current brain or subdural metastases Active brain or subdural metastases Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least weeks before starting treatment in this study