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A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer

Thank you

Trial Information

A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer


Inclusion Criteria:



- Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel
is indicated.

- 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:

- Active brain metastases.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the tolerability

Outcome Time Frame:

duration of study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AMP-010

NCT ID:

NCT00327288

Start Date:

October 2005

Completion Date:

July 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Breast Cancer
  • Prostate Cancer
  • Hormone refractory prostate cancer
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location

Investigational Site 008Houston, Texas  77030