Serbonnes

Researchers are evaluating ART0380, a new oral drug that targets ATR kinase, in adults with advanced or metastatic solid tumors, including ovarian, peritoneal, fallopian tube, endometrial, colorectal, pancreatic, and acinar cell cancers. This open-label Phase IIIa study aims to find the recommended safe dose of ART0380 alone and combined with gemcitabine or irinotecan, understand side effects, and assess early signs of effectiveness. Participants will receive ART0380 either alone or in combination with gemcitabine or irinotecan in 21-day treatment cycles. ART0380 dosing schedules include intermittent or continuous oral administration. Gemcitabine is given on Days 1 and 8, and irinotecan is given as a 90-minute infusion on Days 1 and 8. The study has multiple parts evaluating different dosing regimens and patient groups, including dose escalation and dose expansion cohorts, with some participants randomized to receive combination therapy or gemcitabine alone. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, blood tests for safety and pharmacokinetics, and tumor marker evaluations over several months. Researchers will monitor side effects from the treatments and measure outcomes such as maximum tolerated dose, progression-free survival, response rates, and overall survival. The study includes follow-up for up to 24 months to observe long-term effects.

Researchers are evaluating a treatment for advanced breast cancer that is estrogen receptor-positive, HER2-negative, and has a specific ESR1 gene mutation. The study aims to find out how well a combination of elacestrant, a selective estrogen receptor degrader, and everolimus, a kinase inhibitor, works in patients whose cancer has progressed despite prior endocrine therapy and CDK46 inhibitor treatment. The study follows strict guidelines to ensure patient safety and compliance with international clinical standards. Participants will be randomly assigned to one of two groups. One group will receive elacestrant at 345 mg plus everolimus at 7.5 mg orally once daily, while the other group will receive elacestrant at the same dose plus a placebo instead of everolimus. Treatments will be given in 28-day cycles and continue until disease progression, unacceptable side effects, or other reasons for stopping the treatment occur. After stopping treatment, patients will be followed every three months for up to one year to monitor survival and any new cancer therapies. During the study, patients will undergo scans such as CT or MRI to confirm disease status, and tests to assess tumor markers and gene mutations. Researchers will monitor treatment effects, safety, and quality of life using questionnaires like the EQ-5D-5L and EORTC QLQ-C30 and QLQ-BR42. Side effects, blood counts, liver and kidney function, heart activity, and overall health status will be regularly checked. The main outcome is progression-free survival, measuring how long patients live without cancer worsening during treatment, with other outcomes including overall survival and treatment response. The total study duration for each participant averages about 12 months.

This research aims to create a national registry for patients suffering from parietal endometriosis, a condition involving nodules in the abdominal wall. It is conducted by a multidisciplinary radiosurgery team and focuses on patients treated with either surgical removal or percutaneous cryoablation. The study will follow participants for three years after treatment to gather comprehensive data on this condition. Patients with parietal endometriosis will be recorded in the registry based on their treatment type either cryoablation or surgery. The study does not involve experimental treatment but observes patients undergoing these procedures. The registry will collect information throughout the treatment and follow-up period, capturing data at multiple time points including one month, six months, one year, two years, and three years after treatment. Participants will be monitored regularly with clinical evaluations, imaging tests such as MRI and ultrasound, and quality of life questionnaires to assess treatment effects and complications. The study will track the epidemiology, imaging characteristics, aesthetic impact, complication rates, and recurrence of nodules. Safety assessments and quality of life measures will be collected throughout the three-year follow-up to understand long-term outcomes of the treatments.