Satara

Researchers are evaluating whether Nuvastatic can reduce cancer-related fatigue in adults with stage IV colon cancer who are undergoing first-line chemotherapy. The study aims to determine if Nuvastatic improves fatigue scores compared to placebo and if it is safe and well tolerated in this patient group. This phase 3 trial focuses on supportive care to improve quality of life during chemotherapy. Participants will be randomly assigned to receive either Nuvastatic or a placebo, both given as 1000mg sachets taken three times daily. Treatment with these sachets will continue for three cycles of 20 days each, totaling approximately 60 days, alongside their standard chemotherapy regimen. Blood samples for biomarkers such as CEA and CA-125 will be collected at screening and at the end of treatment. Throughout the study, participants will complete patient diaries and fatigue assessments to track changes in cancer-related fatigue. Researchers will monitor fatigue levels from screening up to 12 weeks and assess overall quality of life and functional improvements at baseline and study end. Safety and tolerability of Nuvastatic will also be observed during this period.

Researchers are conducting a Phase 1, open-label, dose escalation study to assess the safety, pharmacokinetics PK, and pharmacodynamics PD of an oral drug called AUR112 in patients with relapsed advanced lymphomas. This first-in-human trial aims to find safe and tolerable doses of AUR112 for future studies. The study is led by Aurigene Discovery Technologies Limited and focuses on patients with relapsed or refractory non-Hodgkin lymphoma NHL, chronic lymphocytic leukemia CLL, or Hodgkin disease who have exhausted other effective therapies. Participants will receive AUR112 once daily at increasing dose levels ranging from 100 mg to 1200 mg. The dose escalation follows a classic 33 design, where safety and biological activity data guide dose increases. The study will continue increasing doses until safety limits are reached or biologically active doses are identified. This approach helps determine the most appropriate doses for future clinical trials. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over the first 28 days cycle 1. Researchers will also measure various PK parameters like maximum concentration, time to maximum concentration, and area under the curve on specific days. Assessments include laboratory tests, physical exams, and safety evaluations. The study will help identify doses for further research while ensuring participant safety throughout the trial period.