Skip to main content
OpenTrials
Completed

NCT Number: NCT00327288

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site 008

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

imexon

Drug

IV variable dosages, days 1-5 every 21 days for duration of study

Other names: Amplimexon

docetaxel

Drug

IV once every 21 days for duration of study

Other names: Taxotere

Primary outcomes

  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 outcomes

  1. Record any objective tumor responses which may occur

    Time frame: duration of study

Sponsors and collaborators

Lead sponsor

AmpliMed Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 18, 2006
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.