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Sponsored by: |
AmpliMed Corporation |
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Information provided by: | AmpliMed Corporation |
ClinicalTrials.gov Identifier: | NCT00327288 |
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 | Intervention | Phase |
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Non-Small Cell Lung Cancer Breast Cancer Prostate Cancer |
Drug: imexon Drug: docetaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Docetaxel plus imexon
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AmpliMed Corporation ( Evan Hersh, VP Medical Affairs ) |
Study ID Numbers: | AMP-010 |
Study First Received: | May 17, 2006 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00327288 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hormone refractory prostate cancer |
Thoracic Neoplasms Prostatic Diseases Skin Diseases Genital Neoplasms, Male Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Hormones Carcinoma |
Docetaxel Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Breast Diseases Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Prostatic Diseases Genital Neoplasms, Male Skin Diseases Antineoplastic Agents Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms Breast Diseases Neoplasms, Glandular and Epithelial |