- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057395
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies
June 23, 2005 updated by: Aronex Pharmaceuticals
A Phase I/II 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Santa Monica, California, United States, 90404
- John Wayne Cancer Institute
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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.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
First Submitted
April 1, 2003
First Submitted That Met QC Criteria
April 1, 2003
First Posted (Estimate)
April 2, 2003
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 2004
More Information
Terms related to this study
Keywords
- Hepatocellular Carcinoma
- Ovarian Neoplasms
- Pancreatic Cancer
- Colorectal Cancer
- Ovarian Cancer
- Esophageal Cancer
- Carcinoma, Hepatocellular
- Colorectal Carcinoma
- Colorectal Neoplasms
- Pancreatic Neoplasms
- Pancreas Cancer
- Ovarian Carcinoma
- Colorectal Tumor
- Esophageal Neoplasms
- Hepatoma
- Neoplasms, Colorectal
- Esophagus Cancer
- Neoplasms, Esophageal
- Pancreas Neoplasms
- Neoplasms, Ovarian
- Ovary Cancer
- Ovary Neoplasms
- Esophagus Neoplasm
- Esophageal Tumors
- Esophagus Tumors
- Ovary Carcinoma
- Neoplasms, Pancreatic
- Neoplasms, Pancreas
- and other solid tumors
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Liver Diseases
- Head and Neck Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Liver Neoplasms
- Intestinal Neoplasms
- Rectal Diseases
- Esophageal Diseases
- Pancreatic Diseases
- Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Colorectal Neoplasms
- Ovarian Neoplasms
- Pancreatic Neoplasms
- Esophageal Neoplasms
- Antineoplastic Agents
- bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)
Other Study ID Numbers
- C-726-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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