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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was  Active, not recruiting
Information provided by:
Aronex Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: April 1, 2003
Last updated: June 23, 2005
Last verified: April 2004
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies

Resource links provided by NLM:

Further study details as provided by Aronex Pharmaceuticals:

Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00057395

United States, California
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Aronex Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00057395     History of Changes
Other Study ID Numbers: C-726-04 
Study First Received: April 1, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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
Esophageal Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Adnexal Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Head and Neck Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 23, 2016