NCT00093119

CompletedPhase 2

Trial of ABI-007 in Previously Treated Patients With Metasta...

Celgene Source

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Other study identifiers

Sponsor study identifier

CA014

Study Type

interventional

Actual enrollment (reported)

75

Locations

1 country

Sites

1

Timeline

Study Start

July 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2005

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 75 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 1, 2004
Actual (reported)
First Posted
October 4, 2004
Actual (reported)
Primary Completion
February 2005
Actual (reported)

Last Updated: April 26, 2017
Status Verified: April 2017
Last Update Submitted: April 25, 2017

Conditions

Melanoma Metastases

Keywords

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.

Secondary Outcomes (1)

Evaluate number of cycles required before patients achieve maximum response

Interventions

ABI-007Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Confirmed Metastatic Melanoma
At least 18 years old

Sponsors & Collaborators

Celgene
Industrylead

Study Sites (1)

Abraxis BioScience Inc.

Durham, North Carolina, 27703, United States

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Michael Hawkins
Celgene Corporation
STUDY DIRECTOR

Enrollment

75 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 1, 2004

First Posted

October 4, 2004

Study Start

July 2003

Date type not reported

This date has not been verified as actual or estimated.

NCT00001832

Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma

Phase 2Completed

NCT00001685

Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase

Phase 2Completed

NCT00001705

Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Phase 2Completed

NCT00046423

A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies

Phase 1Completed

NCT00456846

First Line Therapy for Patients With Metastatic Breast Cancer

Phase 2Terminated

NCT02452294

Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

Phase 2Unknown

No other active malignancy

Hemoglobin at least 9

Platelet Count at least 100,000 cells/mm3

ANC at least 1500 cells/mm3

AST \& ALT less than 2.5X upper limit of normal

Total bilirubin less than 1.5mg/dL

Creatine less than 1.5 mg/dL

Alkaline phosphatase less than 2.5X upper limit of normal

Life expectancy of at least 12 weeks

ECOG performance status of 0-1

Patient must provide informed consent

Patient must provide authorization to disclose

You may not qualify if:

Evidence of active brain metastases
The only evidence of metastasis is lytic or blastic bone metastases
Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
Received radiotherapy in last 4wks, except if to a non-target lesion only
Clinically significant concurrent illness
Investigator's opinion that patient unlikely to complete study
Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
History of allergy/hypersensitivity to study drug
Serious Medical Risk Factors determine by the investigator

Contact the study team to confirm eligibility.

Neoplastic Processes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Primary Completion

February 2005

Actual (reported)

Last Updated

April 26, 2017

Record last verified: 2017-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00093119
Data provider: ClinicalTrials.gov
Source updated: 2017-04-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:39 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations