NCT00327600

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

1.5 years

First QC Date

May 17, 2006

Last Update Submit

September 14, 2010

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (3)

  • Determine the maximally tolerated dose of imexon plus DTIC

  • determine the toxicity and tolerability of the combination

  • determine response rate and progression free survival

Secondary Outcomes (1)

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

Study Arms (1)

imexon + DTIC

EXPERIMENTAL
Drug: imexonDrug: DTIC

Interventions

imexonDRUG
imexon + DTIC
DTICDRUG
imexon + DTIC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Investigational Site 009

Los Angeles, California, 90033, United States

Location

Investigational Site 002

Santa Monica, California, 90404, United States

Location

University of CO Anschutz Cancer Pavilion

Aurora, Colorado, 80010, United States

Location

US Oncology Orlando, Cancer Centers of FL

Ocoee, Florida, 34761, United States

Location

US Oncology Albany, New York Oncology

Albany, New York, 12208, United States

Location

US Oncology Kettering

Kettering, Ohio, 45409, United States

Location

US Oncology Greenville, Cancer Centers of the Carolinas

Greenville, South Carolina, 29615, United States

Location

US Oncology, Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Investigational Site 012

Salt Lake City, Utah, 84112, United States

Location

US Oncology, Virginia Oncology Assoc

Norfolk, Virginia, 23502, United States

Location

US Oncology Spokane, Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

Related Publications (1)

  • 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.

    PMID: 20564083RESULT

MeSH Terms

Conditions

Melanoma

Interventions

4-imino-1,3-diazabicyclo(3.1.0)hexan-2-oneDacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Evan Hersh, MD

    AmpliMed Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

July 1, 2005

Primary Completion

January 1, 2007

Study Completion

December 1, 2007

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations

US(11)