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.
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
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.
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.
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