A Randomized Study of Amplimexon With Gemcitabine in Pancreatic Cancer
Summary
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Pancreatic Neoplasms
Intervention
imexon + gemcitabine, imexon placebo + gemcitabine
Location
Birmingham Hematology and Oncology- US Oncology
Birmingham
Alabama
United States
35205
Status
Active, not recruiting
Source
AmpliMed Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00637247
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:18:26-0400
Clinical Trials
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
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 pre...
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
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...
A Safety and Efficacy Trial of Amplimexon Plus Taxotere in Metastatic Non-Small Cell Lung Cancer
Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously treated lung cancer that has spread in the body. Docetaxel is approved by the Food and Drug Admi...
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
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 o...
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
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 gi...
PubMed Articles
USP9X inhibition improves gemcitabine sensitivity in pancreatic cancer by inhibiting autophagy.
Gemcitabine is the cornerstone of pancreatic cancer treatment. Although effective in most patients, development of tumor resistance to gemcitabine can critically limit its efficacy. The mechanisms res...
Pancreatic cancer is one of the most lethal cancers with limited treatment options. Gemcitabine has been the standard drug for patients with advanced pancreatic cancer. Dasatinib is a competitive inhi...
Gemcitabine-Incorporated G-Quadruplex Aptamer for Targeted Drug Delivery into Pancreas Cancer.
Gemcitabine has been considered a first-line chemotherapy agent for the treatment of pancreatic cancer. However, the initial response rate of gemcitabine is low and chemoresistance occurs frequently. ...
miR-301a plays a pivotal role in hypoxia-induced gemcitabine resistance in pancreatic cancer.
Hypoxia is a hallmark of pancreatic cancer (PC) and is associated with gemcitabine resistance. However, the mechanisms underlying hypoxia-induced gemcitabine resistance in PC remain greatly unknown. O...
Chemotherapy-induced immunosuppression poses an additional challenge to its limited efficacy in pancreatic cancer (PC). Here we investigated the effect of gemcitabine on macrophages, which are the fir...
Medical and Biotech [MESH] Definitions
Pancreatic Neoplasms
Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).
Pancreatic Polypeptide
A 36-amino acid pancreatic hormone that is secreted mainly by endocrine cells found at the periphery of the ISLETS OF LANGERHANS and adjacent to cells containing SOMATOSTATIN and GLUCAGON. Pancreatic polypeptide (PP), when administered peripherally, can suppress gastric secretion, gastric emptying, pancreatic enzyme secretion, and appetite. A lack of pancreatic polypeptide (PP) has been associated with OBESITY in rats and mice.
Pancreatic Extracts
Extracts prepared from pancreatic tissue that may contain the pancreatic enzymes or other specific uncharacterized factors or proteins with specific activities. PANCREATIN is a specific extract containing digestive enzymes and used to treat pancreatic insufficiency.
Neoplasms By Site
A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.
Trypsin Inhibitor, Kazal Pancreatic
A pancreatic trypsin inhibitor common to all mammals. It is secreted with the zymogens into the pancreatic juice. It is a protein composed of 56 amino acid residues and is different in amino acid composition and physiological activity from the Kunitz bovine pancreatic trypsin inhibitor (APROTININ).
