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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer; Breast Cancer; Prostate Cancer
• Interventions: Drug: imexon; Drug: docetaxel

• Registration Number: NCT00327288
• Lead Sponsor: AmpliMed Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-18
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	docetaxel	Docetaxel plus imexon
A	imexon	Docetaxel plus imexon

Primary Outcome Measures

Name	Time	Method
Determine the tolerability	duration of study
determine the maximally tolerated dose (MTD)	duration of study
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel	duration of study
correlate changes in plasma glutathione (GSH) levels with imexon dose levels	cycle 1

Secondary Outcome Measures

Name	Time	Method
Record any objective tumor responses which may occur	duration of study

Trial Locations

Locations (1)

Investigational Site 008; 🇺🇸 Houston, Texas, United States