Pfizer Halts Cancer Drug Trial Enrollment After Patient Deaths
Enrollment in a late-stage clinical trial of an experimental Pfizer Inc. lung cancer drug has been stopped early after some people taking the drug died or suffered other serious adverse events, the company said.
The drug, called figitumumab, was seen as a potential new blockbuster for Pfizer, which has seen sales of some of its top drugs fall recently due to facing generic competition for the first time. Nearly 700 patients had been enrolled in the Phase III trial of the drug and officials planned to enroll 820, according to a Reuters news report.
Independent safety monitors overseeing the trial stopped taking new patients after reporting fatal and severe health problems in some people taking figitumumab. The study, called Advigo 1016, tested the drug in patients with non-small cell lung cancer when it is given along with two older cancer therapy drugs, carboplatin and paclitaxel. Some patients were given just the older drugs and not figitumumab.
Researchers were trying to determine whether figitumumab, an IGF-1R inhibitor, was safe and effective as a potential initial cancer treatment. Earlier mid-stage clinical trials had determined that some metabolic side effects were evident with the use of figitumumab, officials said.
A separate late-state study evaluating figitumumab in combination with Roche and OSI Pharmaceuticals’ Tarceva is still enrolling new patients, Pfizer said, according to Reuters. Also, patients already taking the drug as part of the trial that is no longer enrolling patients can keep taking the drug under a doctor’s supervision, the company said.
Other Cancer Drugs in Clinical Trial Trouble
In September, drug maker Roche stopped enrolling breast cancer patients in a study of the drug Avastin after some patients developed heart failure. That study was sponsored by the National Cancer Institute and designed to test Avastin’s effectiveness at treating breast cancer when it is used along with chemotherapy.
Six early-stage breast cancer patients admitted to the Avastin study developed symptoms of heart failure, a potentially fatal condition in which the heart is no longer able to effectively pump blood through the body.
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