NCT00327288

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: AmpliMed Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-small Cell Lung Cancer
• Breast Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	imexon	IV variable dosages, days 1-5 every 21 days for duration of study
DRUG	docetaxel	IV once every 21 days for duration of study

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-05-18
• Last updated: 2015-06-24

Locations

1 site across 1 country: United States