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Study of Weekly LOC-paclitaxel Injection for Melanoma

NCT01039844 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-10-27

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of LOC-paclitaxel when given to patients with metastatic melanoma. The safety of this drug and if it can control the disease is also being studied.

Conditions

Interventions

DRUG

LOC-paclitaxel

Phase I Starting Dose: 100 mg/m\^2 IV (intravenously) 1 hour infusion on Day 1, 8, 15, 22 and 29; and repeated every 42 days (6 weeks) per cycle. Phase II Starting Dose: Maximum tolerated dose from Phase I.

Sponsors & Collaborators

  • American Regent, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rodabe N. Amaria, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01039844 on ClinicalTrials.gov