An upcoming phase 2 study will explore if the transdermal (through the skin) delivery of a drug commonly used to treat nausea and vomiting will result in no nausea, no vomiting and no use of rescue medicines in patients with cancer receiving chemotherapy.
Researchers are launching a trial to investigate a new way of administering Zyprexa (olanzapine), an oral drug that is commonly used to control chemotherapy-induced nausea and vomiting (CINV), called STAR-OLZ, according to the agent’s manufacturer, Straton Therapeutics.
STAR-OLZ is a transdermal (through the skin) method of delivering Zyprexa over the course of five days. It will be studied in the upcoming phase 2 TROPIC-I clinical trial, which will compare a common three-drug regimen used to treat CINV with or without the use of STAR-OLZ in patients receiving cancer treatments that are highly emetic — meaning that they are likely to induce nausea and/or vomiting.
“STAR-OLZ represents the first product to be developed for (Food and Drug Administration [FDA]) approval using the total control primary endpoint, potentially improving outcomes and quality of life for patients,” said Dr. Jamie Oliver, chief medical officer of Starton Therapeutics, in a news release. “Total control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a complete response endpoint which only measures vomiting and the need for rescue medications.”
CINV is a common, and sometimes debilitating side effect of chemotherapy treatment that can lead to other complications. Prior research has linked chemotherapy-related nausea with anxiety and depression in patients with cancer, highlighting an urgent need to mitigate these symptoms.
A prior phase 1 in-human bioavailability study showed that STAR-OLZ, which is a patch worn on the skin, had acceptable tolerability and delivered about 60% less drug than when taken orally.
Of note, while the anti-psychotic drug Zyprexa is commonly used to treat CINV in patients with cancer, it is not currently approved by the FDA for any nausea/vomiting indications.
Researchers plan on enrolling approximately 120 patients with cancer who are undergoing highly emetic chemotherapy. TROPIC-I is planned to be conducted in more than 20 cancer centers across the United States.
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