Pancreatic cancer clinical trial terminated

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Pancreatic cancer clinical trial terminated

On August 8, 2012, the pharmaceutical company Amgen announced that they will discontinue their Phase III clinical trial testing their experimental compound ganitumab (AMG 479) in combination with gemcitabine in patients with untreated metastatic pancreatic cancer. AMG 479 belongs to a category of drugs known as targeted agents, which attack a specific protein pathway thought to be important to the growth of pancreatic cancer cells.

The trial was designed to include an interim analysis that took place before the trial was officially scheduled to end, to determine whether the combination of treatments seems to be more effective than gemcitabine alone. Unfortunately, the interim data suggested that AMG 479 in combination with gemcitabine did not improve the overall survival of patients. There were no additional toxicities observed in patients treated with the combination.

Although these results are disappointing, all drugs and drug combinations must be carefully tested in a controlled clinical trial setting to determine safety and efficacy. Preliminary studies in the laboratory and trials investigating a smaller number of patients suggested that AMG 479 held promise in the treatment of pancreatic cancer. However, a larger scale Phase III trial was necessary to decide whether the drug combination was beneficial as compared to the standard treatment, gemcitabine.

It is also important to note that patients participating in clinical trials are carefully monitored and trials will be quickly stopped if patient benefit is not observed. Clinical trials that do not yield positive results lead researchers to change their focus to explore other agents that might be beneficial. Rigorous clinical trials are the only way that researchers can develop new treatment options for pancreatic cancer.

The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. For more information about ongoing clinical trials or any other questions about pancreatic cancer treatment or diagnosis, please contact a PanCAN Patient Services Case Manager toll-free at 877-272-6226 or email patientservices@pancan.org. PanCAN Patient Services Case Managers are available M-F 7am-5pm Pacific Time.

Click here to read Amgen’s press release.