Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients

Completed · Phase 1

Conditions studied: Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer

In brief

Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.

Key facts

Study ID

NCT00327288

Run by

AmpliMed Corporation

People needed

34

Starts

2005-10-01

Expected to finish

2008-07-01

Last updated by the study team

2015-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Active brain metastases.

Where it is running

• Investigational Site 008 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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