A Safety And Effectiveness Study Of Aroplatin In Patients With Advanced Solid Malignancies

Study Overview

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

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

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

Esophageal Neoplasms
Hepatocellular Carcinoma
Colorectal Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Neoplasms

DRUG: Aroplatin (Liposomal NDDP, L-NDDP)

C-726-04

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2003-04-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2005-06-23
First Submitted that Met QC Criteria 2003-04-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2005-06-24
First Posted (ESTIMATED) 2003-04-02	Results First Posted N/A	Last Verified 2004-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record