An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors

Inclusion criteria

• Age ≥ 18 years
• Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available:colorectal; gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer; ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative breast
• Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125)
• Life expectancy ≥ 12 weeks
• Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies
• Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
• Peripheral neuropathy ≥ CTCAE v4 grade 2
• Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
• Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control
• Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed as part of the screening examination.
• Patients treated with a calcium channel blocker or who require combination of more than 2 antihypertensives to control blood pressure.
• Other protocol-defined exclusion criteria may apply.