A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis
Both
Neoplasm Metastasis
Trial Information
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximally tolerated dose
Safety Issue:
Yes
Principal Investigator
Evan Hersh, MD
Investigator Role:
Study Director
Investigator Affiliation:
AmpliMed Corporation
Authority:
United States: Food and Drug Administration
Study ID:
AMP-011
NCT ID:
NCT00327223
Start Date:
November 2005
Completion Date:
October 2006
Related Keywords:
- Neoplasm Metastasis
- Metastatic cancer
- Disseminated malignant disease
- Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| US Oncology Indiana | Indianapolis, Indiana 46227 |
| US Oncology Albany, New York Oncology | Albany, New York 12208 |
| Investigational Site 014 | Temple, Texas 76508 |
| US Oncology, Tyler Cancer Center | Tyler, Texas 75702 |
