Pfizer Stops Enrolling Patients in Lung Cancer TrialOct 12, 2009 | Parker Waichman LLP
Pfizer Inc. has stopped enrolling people in a trial for the experimental lung cancer drug, figitumumab, because of a higher number of adverse events, including deaths, among patients treated with the drug. According to The Wall Street Journal, figitumumab was in a Phase III trial when enrollment was halted.
Figitumumab is known as a IGF-1R inhibitor, a class of drugs which block a substance in the body known as insulin-like growth factor. Such drugs are biologics, and are made from living cells. According to The Wall Street Journal, Merck & Co., Eli Lilly & Co. and Biogen Idec Inc. are all developing similar medications.
The figitumumab trial under scrutiny began in March 2008, the Journal said. It was to have lasted until 2011 and involve over 800 patients. Some of the patients were given figitumumab, along with paclitaxel and carboplatin, while others received paclitaxel and carboplatin only.
While enrollment of new patients has been halted, patients already enrolled may continue their treatment in accordance with the trial design and in consultation with their doctors, the Journal said. A separate study, which tests figitumumab with the drug Tarceva, continues to enroll new patients.
The figitumumab study marks the second time in less than a month that enrollment in a clinical trial involving a cancer drug was suspended over safety concerns. In late September, enrollment was stopped in an Avastin trial after six patients developed congestive heart failure.
The late-stage trial was testing Avastin in combination with chemotherapy for treatment of early-stage breast cancer. As we reported at the time, five of the six cases of congestive heart failure were “resolved” after the patients stopped taking both Avastin and the chemotherapy treatment. There was no information available for the sixth, but none of the six have died. That Avastin study was slated to enroll 4,950 patients, and so far 3,439 had joined since November 2007.