AmpliMed Malignant Melanoma, Amplimed is a cancer research chemotherapy corporation with a drug class that features novel mechanisms of action that can defeat MDR and some toxicities

Non-Small Cell Lung Cancer (NSCLC)

Protocol AMP-024

AMP-024 is a single arm Phase II study to assess the efficacy of the combination of Amplimexon® with Taxotere® (docetaxel) in patients with previously treated NSCLC. Amplimexon® is administered at 1300 mg/m2 per day on days 1-5 and Taxotere® is administered at 75 mg/m2 on day 1 of each 3 week cycle. The primary endpoint is response rate and the secondary endpoints are progression free survival, overall survival and toxicity/tolerability. The study is planned to open in the fall of 2008 and will be conducted in multiple centers in the U.S. It is anticipated to enroll approximately 80 patients.

Who can participate?

In order to participate in the study, a person must meet the following criteria:

Inoperable metastatic cancer of the lung.
Blood cell counts and blood chemistries at or near normal range.
Able to perform the activities of daily living.
A projected life expectancy of at least 2 months.
If female neither pregnant nor nursing.
Willing to use contraceptives to prevent pregnancy.
No other active malignancy.
No other serious illnesses.
At least one prior chemotherapy for metastatic disease.
No current other drug therapy for the cancer or steroid therapy.
No current active spread of the disease to the brain.
Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.

Please note there are also additional criteria. The study center will determine if you meet all of the requirements for enrollment.

Risks

While Taxotere® is known to benefit some patients with non small cell lung cancer, the effects of the combination of Taxotere® and Amplimexon® have not yet been established. This invesitgational combination may not benefit all patients and may result in different or more severe side effects than either drug alone. These side effects could be life threatening. There may be side effects that are not known or not predicted at this time, but that may occur at the time of treatment or later.

Further information

For more information on AMP-024 or to find the clinical trial site nearest you, please click here.