Overview

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.