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Completed

NCT Number: NCT00046423

A Trial of ABI-007 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Abraxis Bioscience, Inc.

Durham, North Carolina, 27703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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 Performance 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

Treatment and study plan

ABI-007

Drug

Sponsors and collaborators

Lead sponsor

Celgene Corporation

Industry

Registry information

Official study title

A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-hematologic Malignancies

Important dates

Study start
2000
First posted
Oct 3, 2002
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.