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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057395
Recruitment Status : Unknown
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2003
Last Update Posted : June 24, 2005
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Hepatocellular Carcinoma Colorectal Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Neoplasms Drug: Aroplatin (Liposomal NDDP, L-NDDP) Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057395

United States, California
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Aronex Pharmaceuticals Identifier: NCT00057395     History of Changes
Other Study ID Numbers: C-726-04
First Posted: April 2, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004

Keywords provided by Aronex Pharmaceuticals:
Esophageal Neoplasms
Esophagus Neoplasm
Esophagus Cancer
Esophageal Cancer
Esophageal Tumors
Esophagus Tumors
Neoplasms, Esophageal
Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumor
Neoplasms, Colorectal
Ovarian Neoplasms
Ovary Neoplasms
Ovary Cancer
Ovary Carcinoma
Ovarian Cancer
Ovarian Carcinoma
Neoplasms, Ovarian
Pancreatic Neoplasms
Pancreatic Cancer
Pancreas Neoplasms
Pancreas Cancer
Neoplasms, Pancreatic
Neoplasms, Pancreas
and other solid tumors

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Colorectal Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders