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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 IndianaIndianapolis, Indiana  46227
US Oncology Albany, New York OncologyAlbany, New York  12208
Investigational Site 014Temple, Texas  76508
US Oncology, Tyler Cancer CenterTyler, Texas  75702