CLINICAL TRIALS PROFILE FOR IMEXON

Clinical Trials for Imexon

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00327223 ↗	Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy	Completed	AmpliMed Corporation	Phase 1	AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
NCT00327249 ↗	Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients	Completed	AmpliMed Corporation	Phase 1/Phase 2	AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma
NCT00327288 ↗	Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients	Completed	AmpliMed Corporation	Phase 1	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.
NCT00327327 ↗	Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma	Completed	AmpliMed Corporation	Phase 1	AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
NCT00327600 ↗	Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma	Completed	AmpliMed Corporation	Phase 1/Phase 2	AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
NCT00637247 ↗	A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer	Completed	AmpliMed Corporation	Phase 2	The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Clinical Trial Conditions for Imexon

Condition Name

Condition Name
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	1
Pancreatic Neoplasms	1
Diffuse Large B Cell Lymphoma	1
Prostate Cancer	1

Condition MeSH

Condition MeSH
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	2
Lymphoma, Mantle-Cell	1
Burkitt Lymphoma	1
Lymphoma, Large B-Cell, Diffuse	1

Clinical Trial Locations for Imexon

Trials by Country

Trials by Country
Location	Trials
United States	52

Trials by US State

Trials by US State
Location	Trials
Texas	6
New York	5
Washington	3
Virginia	3
Florida	3

Clinical Trial Progress for Imexon

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	3
Phase 1/Phase 2	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	7
Withdrawn	1

Clinical Trial Sponsors for Imexon

Sponsor Name

Sponsor Name
Sponsor	Trials
AmpliMed Corporation	7
University of Arizona	1
University of Rochester	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	7
Other	2