Inclusion Criteria:
Part 1 only:
- Subjects with a histological diagnosis of advanced cancer (solid tumors or central
nervous system [CNS] tumors) with disease that is recurrent or refractory to standard
therapy or for whom standard therapy is not available (histological confirmation waived for
brain stem gliomas and optic pathway tumors)
Part 2 only:
- Subjects with histologically confirmed diagnosis of refractory or relapsed:
Neuroblastoma, High-grade gliomas: glioblastoma multiforme, anaplastic astrocytomas,
and other high-grade gliomas (histological confirmation waived for brain stem
gliomas), Rhabdomyosarcoma.
- Measurable disease (for subjects with neuroblastoma, evaluable disease as determined
by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted).
Exclusion Criteria:
- Subjects receiving enzyme-inducing anticonvulsants.
- Pulmonary hypertension or pneumonitis
- Active infection or serious intercurrent illness
- Other exclusions apply