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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
Not Enrolling
Both
Neoplasm Metastasis

Thank you

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