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
Sponsor:
Information provided by:
Aronex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00057395
First received: April 1, 2003
Last updated: June 23, 2005
Last verified: April 2004
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057395

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

Additional Information:
No publications provided

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
Hepatoma
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:
Neoplasms
Carcinoma
Colorectal Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pancreatic Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on July 20, 2014