Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093119

Enrollment

Registered

2004-10-04

Start date

2003-07-31

Completion date

Unknown

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Metastases

Keywords

Metastatic Melanoma

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.

Interventions

DRUGABI-007

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed Metastatic Melanoma * At least 18 years old * 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.	—

Secondary

Measure	Time frame
Evaluate number of cycles required before patients achieve maximum response	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026