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

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327600
First received: May 17, 2006
Last updated: September 14, 2010
Last verified: September 2010

May 17, 2006
September 14, 2010
July 2005
January 2007   (final data collection date for primary outcome measure)
  • Determine the maximally tolerated dose of imexon plus DTIC [ Designated as safety issue: Yes ]
  • determine the toxicity and tolerability of the combination [ Designated as safety issue: Yes ]
  • determine response rate and progression free survival [ Designated as safety issue: No ]
  • Determine the maximally tolerated dose of imexon plus DTIC
  • determine the toxicity and tolerability of the combination
  • determine response rate and progression free survival.
Complete list of historical versions of study NCT00327600 on ClinicalTrials.gov Archive Site
Determine effects of the drug combination on plasma thiol levels and other biomarkers [ Designated as safety issue: No ]
Determine effects of the drug combination on plasma thiol levels and other biomarkers.
Not Provided
Not Provided
 
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: imexon
  • Drug: DTIC
Experimental: imexon + DTIC
Interventions:
  • Drug: imexon
  • Drug: DTIC
Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.25119.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
December 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00327600
AMP-005
Yes
Evan Hersh, VP Medical Affairs, AmpliMed Corporation
AmpliMed Corporation
Not Provided
Study Director: Evan Hersh, MD AmpliMed Corporation
AmpliMed Corporation
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP