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

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327288
First received: May 17, 2006
Last updated: September 14, 2010
Last verified: September 2010

May 17, 2006
September 14, 2010
October 2005
July 2008   (final data collection date for primary outcome measure)
  • Determine the tolerability [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • determine the maximally tolerated dose (MTD) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • correlate changes in plasma glutathione (GSH) levels with imexon dose levels [ Time Frame: cycle 1 ] [ Designated as safety issue: No ]
  • Determine the tolerability
  • determine the maximally tolerated dose (MTD)
  • determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
  • correlate changes in plasma glutathione (GSH) levels with imexon dose levels.
Complete list of historical versions of study NCT00327288 on ClinicalTrials.gov Archive Site
Record any objective tumor responses which may occur [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Record any objective tumor responses which may occur.
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer
  • Breast Cancer
  • Prostate Cancer
  • 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
Experimental: A
Docetaxel plus imexon
Interventions:
  • Drug: imexon
  • Drug: docetaxel
Moulder S, Dhillon N, Ng C, Hong D, Wheler J, Naing A, Tse S, La Paglia A, Dorr R, Hersh E, Boytim M, Kurzrock R. A phase I trial of imexon, a pro-oxidant, in combination with docetaxel for the treatment of patients with advanced breast, non-small cell lung and prostate cancer. Invest New Drugs. 2010 Oct;28(5):634-40. Epub 2009 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00327288
AMP-010
No
Evan Hersh, VP Medical Affairs, AmpliMed Corporation
AmpliMed Corporation
Not Provided
Not Provided
AmpliMed Corporation
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP