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Regorafenib with brand name Stivarga was approved by US-FDA in February 2013, to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. Regorafenib is developed by Bayer and jointly promoted by Bayer and Onyx Pharmaceuticals, Inc. in the U.S. Gastro Intestinal Stromal Tumour (GIST) is the most common form of cancer arising from the transformed cells of muscle wall of the gastrointestinal tract. GIST represents a life-threatening malignancy if the disease has spread to other parts of the body or if the disease is unable to be surgically removed with curative purpose. There are two types of GISTs, Large GISTs and Small GISTs. Larger tumors usually cause symptoms in contrast to those found incidentally which tend to be smaller and have better diagnosis. Although the majority of malignant tumors are large, small GISTs may also demonstrate clinically aggressive behavior. The incidence of GIST is estimated to be 11 to 20 patients per million per year. Symptoms for GIST are trouble in swallowing, gastrointestinal haemorrhage or metastases in the liver. Intestinal obstruction is rare due to the tumor's outward pattern of growth. Often, there is a history of vague abdominal pain or discomfort, and the tumor has become rather large by time the diagnosis is made. Stivarga with active substance regorafenib is an oral multi-kinase inhibitor that targets oncogenesis, tumor growth and maintenance of the tumormicroenvironment signaling by inhibiting multiple protein kinases. The FDA approval of Stivarga for GIST was based on results from the pivotal Phase III international, multi-centre, randomized trial in 2:1 ratio with double-blinded design. It was a placebo-controlled trial in 199 subjects with GIST which cannot be surgically removed, or in subjects who had been previously treated with imatinib mesylate and sunitinib malate. The subjects received 160 mg regorafenib orally once daily with best supportive care or placebo with best supportive care for the first 21 days of each 28-day cycle. Treatment continued until there was a disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Progression free survival is a condition in which the disease being treated does not get worse. This primary end-point was based on disease assessment by independent radiological review using modified RECIST 1.1 criteria. The percentage of subjects with death or progression was found to be 62% in the Stivarga arm and 96% in the placebo arm. The median PFS was 4.8 months for stivarga arm and 0.9 months for placebo arms. Stivarga is supplied as a tablet for oral administration. The recommended dose is 160 mg (four 40 mg tablets) taken orally once daily for the first 21 days of each 28 day cycle. Stivarga should be swallowed whole and taken with a low-fat breakfast. In clinical trials, the most frequently reported drug-related adverse events in Regorafenib-treated patients versus placebo-treated patients were asthenia/fatigue, hand-foot skin reaction (HFSR), diarrhea, decreased appetite and food intake, hypertension, mucositis, dysphonia, infection, pain decreased weight, gastrointestinal and abdominal pain, rash, fever and nausea. The most serious adverse drug reactions in patients receiving Stivarga are hepatotoxicity, hemorrhage and gastrointestinal perforation. Thus Strivarga showed a promising effect for the treatment of Gastrointestinal Stromal Tumour and has proven to be a drug of choice compared to the market available drugs Imatinib mesylate and Sunitinib malate. Clinnovo is a clinical innovation company. It is pioneer CRO industry in India. Clinnovo offers professional Clinical Research Course, clinical data management course , SAS and imaging training. Clinnovo has been serving different bio-pharma industries across the world with excellence and high quality. For more information contact at +91 9912868928, 040 64635501
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Strivarga, Gastro Intestinal Stromal Tumour, Clinical Research, Clinical data mangement, regorafenib, treatment for GIST, Drugs for GIST,
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