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Completed

NCT Number: NCT00327600

Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site 009, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malignant melanoma; inoperable stage III or IV disease.
  • Able to perform the activities of daily living.
  • A projected life expectancy of at least 4 months.
  • If female, neither pregnant nor nursing.
  • Willing to use contraceptives to prevent pregnancy.
  • Blood cell counts and blood chemistries in or near normal range.
  • Prior radiation is permitted.
  • No other serious illnesses.
  • No other active malignancy.
  • No serious infections.
  • No other current drug therapy for the cancer or steroid therapy.

Exclusion criteria

  • No prior chemotherapy for the stage III or IV disease.
  • Brain metastases

Treatment and study plan

imexon

Drug

DTIC

Drug

Primary outcomes

  1. Determine the maximally tolerated dose of imexon plus DTIC

  2. determine the toxicity and tolerability of the combination

  3. determine response rate and progression free survival

Secondary outcomes

  1. Determine effects of the drug combination on plasma thiol levels and other biomarkers

Sponsors and collaborators

Lead sponsor

AmpliMed Corporation

Industry

Registry information

Official study title

A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 18, 2006
Registry last updated
Sep 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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