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

Aronex Pharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Ovarian Neoplasms

Neoplasms

Hepatocellular Carcinoma

Colorectal Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Treatments

Drug: Aroplatin (Liposomal NDDP, L-NDDP)

Study type

Interventional

Funder types

Industry

Identifiers

C-726-04

Details and patient eligibility

About

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

Full description

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:

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.