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Pancreas Cancer News and Archives | |
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For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer | |
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Early Data Shows Positive
Indicators of Anti-Tumor Activity with Gimatecan, a Novel Oral
Camptothecin Derivative Preliminary data showing positive indicators of anti-tumor activity with the oral camptothecin derivative gimatecan (ST1481) were presented today at the 39th annual meeting of the American Society of Clinical Oncology. The data also show improvements in dose schedule-dependent tolerability in patients with solid tumors, confirming the development potential of gimatecan as a possible cancer treatment. These preliminary data are from two Phase I studies of gimatecan in patients with advanced solid tumors and one Phase I/II study of gimatecan in patients with recurrent or refractory malignant glioma (brain cancer). The Phase I studies are investigating maximum tolerated dose and dose scheduling in patients with malignant glioma, non-small-cell lung cancer, breast cancer, melanoma, and colon adenocarcinoma. The Phase I/II study is also investigating potential dosing in recurrent malignant glioma patients receiving treatment with enzyme inducing antiepileptic drugs (EIAED). Enrollment for the trials is ongoing. In these preliminary data, gimatecan appeared to be well tolerated by patients with brain and other solid tumors. "If these effects are confirmed by future studies, gimatecan may become an effective treatment for a variety of solid tumors," said Dr. Paolo Carminati, Director, Research & Development, Sigma-Tau SpA (Pomezia, Italy). "We are encouraged by the initial results of our Phase I/II development of gimatecan." Advanced Solid Tumor Study The ongoing Phase I advanced solid tumor study, being conducted at several US centers, is evaluating an alternative dosing schedule for oral gimatecan -- administered weekly for three weeks of each 28-day cycle. The dose of gimatecan will be increased following each treatment cycle until dose-limiting toxicities are observed. Preliminary results show disease stabilization in one patient with melanoma following four treatment cycles and in one patient with colon adenocarcinoma following five treatment cycles with oral gimatecan. No significant drug-related toxicities have been observed at doses of oral gimatecan ranging from 0.26mg/m2/week to 1.32mg/m2/week. The trial will continue until the maximum tolerated dose and dose-limiting toxicities have been identified. Schedule-Dependency Study The Phase I schedule-dependency study escalated doses of oral gimatecan in three schedules of different duration, 5, 10, or 15 days (5 days/week for one, two or three weeks) of oral gimatecan during each 28-day treatment cycle, to determine the recommended Phase II dose for each schedule. Based on data from 93 patients currently enrolled in the trial, in several European centers, the recommended Phase II doses range from 4.0 mg/m2/cycle to 6.4 mg/m2/cycle, according to schedule and patient pretreatment. Partial responses were observed in two patients with non-small-cell lung cancer, one patient with breast cancer, two patients with endometrial cancer and one patient with rhabdomyosarcoma. In addition, minor or humoral responses were observed in patients with pancreatic and ovarian cancer. Glioma Study All patients in the ongoing Phase I/II dose escalation study received a once-daily dose of oral gimatecan for five consecutive days during the first week of each 28-day cycle. To date 12 patients have been enrolled in the trial. Patients are divided into two treatment arms based on whether they received concurrent EIAED therapy. Four of seven patients in the non-EIAED group had radiographic response or stable disease following two cycles of gimatecan therapy. Four out of five patients in the EIAED group failed to achieve a response, while one patient had stable disease. No dose-limiting toxicities were observed. About Gimatecan Gimatecan is an oral camptothecin derivative under investigation as a potential treatment for advanced malignant solid tumors. In pre-clinical trials gimatecan has been shown to have promising anti-tumor activity. Currently marketed camptothecin derivatives are only administered by intravenous infusion under medical supervision. About Sigma-tau Research, Inc. Sigma-tau SpA (Pomezia, Italy), a privately owned pharmaceutical company, established Sigma-tau Research Inc. (Gaithersburg, MD) to advance its clinical development and regulatory programs in the United States. Sigma-tau is currently engaged in significant R&D efforts to develop novel therapeutic products for oncologic, cardiovascular, metabolic, immunologic and nervous system disorders. In oncology, Sigma-tau's research programs are actively pursuing different therapeutic approaches to the treatment of cancers such as cytotoxics, immunotherapy, and cancer vaccines. Gimatecan is the first Sigma-tau camptothecin derivative in clinical development, and a second drug, ST 2617, is entering pre-clinical development.
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