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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms, Metastases, Neoplasm

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Trial Information

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


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.

Inclusion Criteria


- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Michael J Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CA-005-0

NCT ID:

NCT00046423

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Neoplasms
  • Metastases, Neoplasm
  • Cancer
  • solid tumor
  • Advanced malignancy
  • Taxane therapy
  • Biopsy-proven diagnosis of advanced malignancy
  • Various solid tumors which are refractory
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Abraxis Bioscience, Inc.Durham, North Carolina  27703