Overview

This trial is active, not recruiting.

Conditions esophageal neoplasms, hepatocellular carcinoma, colorectal neoplasms, ovarian neoplasms, pancreatic neoplasms, neoplasms
Treatment aroplatin (liposomal nddp, l-nddp)
Phase phase 1/phase 2
Sponsor Aronex Pharmaceuticals
Trial size 40 participants
Trial identifier NCT00057395, C-726-04

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
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: - Determine the safety and tolerability of Aroplatin
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Aronex Pharmaceuticals.