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

NCT00057395UNKNOWNPHASE1, PHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Aronex Pharmaceuticals

Enrollment

40

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Aroplatin (Liposomal NDDPL-NDDP)

Conditions

Esophageal NeoplasmsHepatocellular CarcinomaColorectal NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsNeoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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.

Locations

John Wayne Cancer Institute, Santa Monica, United States

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