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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating ART0380, an oral drug that blocks ATR kinase, in people with advanced or metastatic solid tumors including ovarian, peritoneal, fallopian tube, endometrial, colorectal, pancreatic ductal adenocarcinoma, and acinar cell carcinoma. The study aims to find the safe dose of ART0380 alone and combined with chemotherapy drugs gemcitabine or irinotecan, understand side effects, and assess its effectiveness. This open-label Phase I/IIa trial includes participants whose cancers have DNA repair defects or lack ATM protein and some specific cancer types. Participants receive ART0380 by mouth in 21-day cycles either intermittently (several days on then off) or continuously daily. Gemcitabine is given on days 1 and 8, and irinotecan is given by 90-minute infusion on the same days in combination groups. The study has different parts to find dosing levels and to evaluate safety, tolerability, pharmacokinetics, and initial effectiveness of ART0380 alone or combined with the chemotherapy drugs. During the study, participants undergo regular evaluations including scans every 6 to 9 weeks to monitor tumor response, and safety assessments for side effects throughout treatment and up to 30 days after the last dose. Researchers track adverse events and measure progression-free survival and tumor response rates over up to 2 years. Participants are expected to be available and willing to follow study procedures and assessments during the trial period.
Actively Recruiting
Researchers are evaluating treatments for advanced breast cancer characterized by estrogen receptor-positive, HER2-negative, and ESR1-mutated tumors. This study focuses on patients whose cancer has progressed despite previous endocrine therapy and CDK4/6 inhibitor treatment. The goal is to determine the effectiveness of combining elacestrant, a selective estrogen receptor degrader, with everolimus, a kinase inhibitor, compared to elacestrant with a placebo. This phase 3 trial aims to assess how well these treatments prolong the time patients live without disease progression or unacceptable side effects. A total of 240 patients will be randomly assigned to one of two groups: one receiving 345 mg of elacestrant plus 7.5 mg of everolimus daily, and the other receiving 345 mg of elacestrant plus a placebo daily. Treatment cycles last 28 days and continue until disease progression, unacceptable toxicity, death, or other reasons for stopping. Patients will be grouped based on the presence of visceral metastases and prior duration of CDK4/6 inhibitor therapy. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are tracked every three months for up to 12 months after the last patient is enrolled. Participants will undergo regular assessments including imaging scans to monitor cancer status and safety evaluations. The main measure is progression-free survival, defined as the time from treatment start until tumor progression, death, or discontinuation for other reasons, monitored on average for 12 months. Safety and treatment effectiveness will be closely followed throughout the study, with additional tumor assessments for those who stop treatment for reasons other than progression until new cancer therapy begins, death, or disease progression occurs.
Actively Recruiting
Researchers are creating a national multicenter registry to study patients suffering from parietal endometriosis, a condition affecting the abdominal wall. This registry is managed by a multidisciplinary radiosurgery team and aims to collect detailed information on patients treated with either cryoablation or surgery. The study focuses on patients with symptoms such as pain, bleeding, or quality of life impact, confirmed by clinical and imaging methods like MRI and ultrasound. Patients included in this registry will have undergone treatment by either percutaneous cryoablation or surgical removal of parietal endometriosis nodules. The study does not involve experimental treatments but records real-world data on these two approaches to managing parietal endometriosis. The treatment details, including the choice of procedure, will be documented in the registry. Participants will be followed for up to three years after their treatment to monitor outcomes and collect data for the registry. The primary outcome is the establishment of this national registry to track the removal of nodules by cryoablation or surgery. Assessments will include clinical evaluations and imaging studies during follow-up to understand the course and results of treatments. Safety and long-term effects will also be monitored, contributing to improved knowledge of parietal endometriosis management.