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

Phase 1

• Conditions: Esophageal Neoplasms; Hepatocellular Carcinoma; Colorectal Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Neoplasms

• Registration Number: NCT00057395
• Lead Sponsor: Aronex Pharmaceuticals

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2003-04-01
• Study First Submitted QC: 2003-04-01
• Study First Posted: 2003-04-02
• Status Verified: 2004-04
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

John Wayne Cancer Institute; 🇺🇸 Santa Monica, California, United States