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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327288
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : June 24, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Breast Cancer Prostate Cancer Drug: imexon Drug: docetaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: A
Docetaxel plus imexon
Drug: imexon
IV variable dosages, days 1-5 every 21 days for duration of study
Other Name: Amplimexon

Drug: docetaxel
IV once every 21 days for duration of study
Other Name: Taxotere

Primary Outcome Measures :
  1. Determine the tolerability [ Time Frame: duration of study ]
  2. determine the maximally tolerated dose (MTD) [ Time Frame: duration of study ]
  3. determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel [ Time Frame: duration of study ]
  4. correlate changes in plasma glutathione (GSH) levels with imexon dose levels [ Time Frame: cycle 1 ]

Secondary Outcome Measures :
  1. Record any objective tumor responses which may occur [ Time Frame: duration of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00327288

United States, Texas
Investigational Site 008
Houston, Texas, United States, 77030
Sponsors and Collaborators
AmpliMed Corporation

Publications of Results:
Responsible Party: AmpliMed Corporation Identifier: NCT00327288     History of Changes
Other Study ID Numbers: AMP-010
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by AmpliMed Corporation:
Hormone refractory prostate cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action