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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00057395
• Other study ID #: C-726-04
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 1, 2003
• Last updated: June 23, 2005

Study information

• Verified date: April 2004
• Source: Aronex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the rate of response and the duration of the response following therapy with Aroplatinin 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Colorectal Neoplasms
• Esophageal Neoplasms
• Hepatocellular Carcinoma
• Neoplasms
• Ovarian Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Aroplatin (Liposomal NDDP, L-NDDP)

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Aronex Pharmaceuticals

Country where clinical trial is conducted

United States,