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

Tracking Information
First Received Date ^ICMJE	April 1, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies
Official Title ^ICMJE	A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Esophageal Neoplasms Hepatocellular Carcinoma Colorectal Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Neoplasms
Intervention ^ICMJE	Drug: Aroplatin (Liposomal NDDP, L-NDDP)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	40
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00057395
Responsible Party
Study ID Numbers ^ICMJE	C-726-04
Study Sponsor ^ICMJE	Aronex Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Aronex Pharmaceuticals
Verification Date	April 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP