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Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma

NCT00130442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2022-06-23

Study results available
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Summary

The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma.

PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients.

Conditions

Interventions

DRUG

PI-88 and dacarbazine

190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

DRUG

dacarbazine or DTIC

intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle

Sponsors & Collaborators

  • Medigen Biotechnology Corporation

    collaborator INDUSTRY

  • Cellxpert Biotechnology Corp.

    lead INDUSTRY

Principal Investigators

  • Michael Millward, MD · Sir Charles Gairdner Hospital

  • Anne Hamilton, PhD · Sydney Cancer Centre

  • Damien Thomson, MD · Princess Alexandra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • Australia

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 NCT00130442 on ClinicalTrials.gov