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A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies
This study has been completed.
Study NCT00046423   Information provided by Abraxis BioScience Inc.
First Received: September 30, 2002   Last Updated: July 14, 2008   History of Changes

September 30, 2002
July 14, 2008
April 2000
 
 
 
Complete list of historical versions of study NCT00046423 on ClinicalTrials.gov Archive Site
 
 
 
A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies
A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-Hematologic Malignancies

This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies. Patients will be given the new chemotherapeutic medicine once a week, by intravenous route, for three weeks, followed by a rest week. Treatment will be repeated in four week cycles if the patient improves on the therapy, and if there are no adverse events that require withdrawal of medication.

This will be a dose-escalating study. ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest. The treatment course will repeat every 28 days. No pretreatment will normally be considered necessary. Patients will have white blood cell and platelet counts monitored as will indications of performance (Karnofsky Performance Status), and will be asked to describe adverse events, if present. Patients will be treated for a minimum of two cycles to be evaluable for the study, and may continue in the study for four cycles within the study, if tumor response and safety parameters warrant continuing. Patients may continue on study medication beyond this at the investigator's discretion.

Phase I
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
  • Neoplasms
  • Metastases, Neoplasm
Drug: ABI-007
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
 
 
  • At least 18 years of age
  • Life expectancy of at least 2 months
  • Off all therapy for at least 3 weeks prior to study drug administration
  • Biopsy-proven diagnosis of advanced malignancy
  • Patients with solid tumors who have failed standard therapy
  • Karnofsky Performance Status of 70% or 0-2 SWOG Perfomance Status
  • Hemoglobin at least 9
  • White Blood Cell count of at least 3000/mm3 with absolute neutrophil count of at least 1500/mm3
  • Platelet count of at least 100,000/mm3
  • Serum Creatinine less than 2 mg/dL
  • Transaminases less than 3X the upper limit of normal
  • Patient must provide informed consent
  • Serum Bilirubin less than 1.5 mg/dL
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00046423
 
CA-005-0
Abraxis BioScience Inc.
 
Study Director: Michael J Hawkins, M.D. Abraxis BioScience Inc.
Abraxis BioScience Inc.
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP