NCT00046423

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2002

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

First QC Date

September 30, 2002

Last Update Submit

November 23, 2016

Conditions

NeoplasmsMetastases, Neoplasm

Keywords

Cancersolid tumorAdvanced malignancyTaxane therapyBiopsy-proven diagnosis of advanced malignancyVarious solid tumors which are refractory

Interventions

ABI-007DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Abraxis Bioscience, Inc.

Durham, North Carolina, 27703, United States

Location

Related Publications (1)

  • Nyman DW, Campbell KJ, Hersh E, Long K, Richardson K, Trieu V, Desai N, Hawkins MJ, Von Hoff DD. Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. J Clin Oncol. 2005 Nov 1;23(31):7785-93. doi: 10.1200/JCO.2004.00.6148.

    PMID: 16258082BACKGROUND

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael J Hawkins, M.D.

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2002

First Posted

October 3, 2002

Study Start

April 1, 2000

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

US(1)