A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies

A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies

To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Primary Objective:

• Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.

Secondary Objective:

• Determine the safety and tolerability of Aroplatin

Inclusion Criteria:

• Advanced solid malignancies;
• Amenable to therapy with DACH platinum agents;
• Measurable disease (RECIST criteria);
• ECOG performance score of 0-2;
• Adequate hematopoietic, liver and renal function;
• Adequate cardiac function (maximum of class II, NYHA);
• Women of childbearing potential must have a negative urine or serum pregnancy test;
• Signed written informed consent;
• Subjects must be willing to be followed during the course of treatment/observation and follow-up.

Exclusion Criteria:

• No other active malignancies;
• No prior therapy with oxaliplatin;
• No known brain metastases;
• Active, uncontrolled infection or other serious medical illnesses;
• Not using or have used any investigational therapy during four weeks before start of protocol treatment.