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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aronex Pharmaceuticals
• Treatments: bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)

Criteria

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.