NCT00327223

Brief Summary

AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
7 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

10 months

First QC Date

May 17, 2006

Last Update Submit

March 12, 2008

Conditions

Neoplasm Metastasis

Keywords

Metastatic cancerDisseminated malignant disease

Outcome Measures

Primary Outcomes (3)

  • Determine the maximally tolerated dose

  • determine the pharmacokinetics

  • determine the toxicity of the drug on the designated schedule

Study Arms (1)

imexon

EXPERIMENTAL

Dose escalation of imexon

Drug: imexon

Interventions

imexonDRUG
imexon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously treated malignant disease of any type.
  • Prior treatment; at least one prior regimen required.
  • Able to perform the activities of daily living.
  • Off prior cancer therapy for at least 4 weeks.
  • If female, neither pregnant nor nursing.
  • Willing to use contraceptives to prevent pregnancy.
  • No other serious illnesses.
  • No other active malignancy.
  • No serious infections.
  • No other current drug therapy for the cancer.
  • Blood counts and blood chemistries in or near normal range.
  • Prior radiation is permitted.

You may not qualify if:

  • No active brain metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

US Oncology Indiana

Indianapolis, Indiana, 46227, United States

Location

US Oncology Albany, New York Oncology

Albany, New York, 12208, United States

Location

Investigational Site 014

Temple, Texas, 76508, United States

Location

US Oncology, Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

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

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Evan Hersh, MD

    AmpliMed Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
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

November 1, 2005

Primary Completion

September 1, 2006

Study Completion

October 1, 2006

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

US(4)