Pediatric Long-Term Follow-up and Rollover Study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Phase 4 lung cancer studies.
Categories organize the public record. They do not determine whether someone is eligible.
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.
People who have surgery on their spine to treat cancer that has spread (metastatic disease) have a high chance of developing dangerous blood clots in the legs or lungs. These blood clots are called deep vein thrombosis (DVT) or pulmonary embolism (PE). In a review of patients at UPMC who had this type of surgery, about 15 out of 100 developed a blood clot within 90 days of leaving the hospital. Right now, patients receive blood-thinning medicine only while they are in the hospital after surgery. Once they go home, the medicine is stopped. There are no guidelines telling doctors whether blood-thinning medicine should continue after patients go home from spine surgery for cancer. However, for other types of major cancer surgery, studies have shown that continuing blood-thinning medicine for about 4 weeks after surgery can help prevent blood clots. This study will test whether taking a blood-thinning medicine called apixaban (brand name Eliquis) by mouth for 30 days after leaving the hospital can help prevent blood clots in patients who have had spine surgery for cancer that has spread. The dose used in this study (2.5 mg twice a day) is the same dose approved by the U.S. Food and Drug Administration (FDA) for preventing blood clots after hip and knee replacement surgery. About 50 adults at UPMC will take part. Participants will take apixaban for 30 days starting the day after hospital discharge. The study team will call participants by phone three times - about 2 days, 31 days, and 91 days after discharge - to check on their health, ask about any bleeding or blood clot symptoms, and assess medication use. No extra clinic visits are required. Results will be compared to a group of 68 patients who had the same type of surgery in the past but did not take apixaban after leaving the hospital. The main goal is to find out if apixaban reduces the rate of blood clots within 90 days of hospital discharge. The study will also track bleeding events and other side effects to determine if this approach is safe. The study hypothesis is that extended blood-thinning medicine after surgery will reduce blood clots compared to the current approach of stopping this medicine at hospital discharge.
In a residency clinic in Baltimore, the investigators propose to conduct a pilot RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control. With a sample of participants from the residency clinic (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. The investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.
Patients with cancer are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage. The primary aim of the Statin Therapy to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who do not otherwise take statin therapy.
This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 11:00 am) or afternoon (12:00pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.
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