Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
- Registration Number
- NCT00327223
- Lead Sponsor
- AmpliMed Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- 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.
Exclusion Criteria
- No active brain metastases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description imexon imexon Dose escalation of imexon
- Primary Outcome Measures
Name Time Method Determine the maximally tolerated dose determine the pharmacokinetics determine the toxicity of the drug on the designated schedule
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
US Oncology, Tyler Cancer Center
🇺🇸Tyler, Texas, United States
US Oncology Indiana
🇺🇸Indianapolis, Indiana, United States
US Oncology Albany, New York Oncology
🇺🇸Albany, New York, United States
Investigational Site 014
🇺🇸Temple, Texas, United States