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Phase 3 trial under way for Stivarga in patients with advanced HCC
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Bayer HealthCare Pharmaceuticals recently launched a phase 3 trial assessing the safety and efficacy of regorafenib for patients with hepatocellular carcinoma who experienced disease progression after therapy with sorafenib, according to a press release.
The double blind, international Regorafenib after Sorafenib in Patients with Hepatocellular Carcinoma (RESORCE) trial will include approximately 530 patients across North and South America, Europe, Asia and Australia. Participants will be randomly assigned (2:1 ratio) to best supportive care and Stivarga (regorafenib) or placebo. Rates of overall and progression-free survival, time to progression and rates of objective tumor response and disease control will be evaluated, along with safety and tolerability.
Stivarga was approved by the FDA in September 2012 for use in patients with metastatic colorectal cancer who had received previous therapy with fluoropyrimidine-, oxaliplatin- or irinotecan-based regimens, along with anti-VEGF or anti-EGFR treatments. The drug also was approved in February for treating gastrointestinal stromal tumors among patients who already had received imatinib mesylate and sunitinib malate.
“There is an unmet need for HCC patients whose disease has progressed after treatment with sorafenib, the only oral systemic therapy shown to improve overall survival in patients with unresectable HCC,” Pamela A. Cyrus, MD, vice president and head of US medical affairs for the company, said in the release. “We look forward to sharing our findings with the scientific community.”
Severe, sometimes fatal hepatotoxicity has occurred among Stivarga recipients in prior clinical trials, according to the release. The drug also increased the incidence of hemorrhage, hand-foot skin reaction (HFSR), severe rash, hypertension and myocardial ischemia and infarction compared with placebo. Commonly observed adverse events related to Stivarga include asthenia/fatigue, HFSR, hypertension, diarrhea, mucositis, dysphonia, rash, infection and loss of appetite.