The study is for patient that are receiving camizestrant as a treatment. The main purpose of study is to change the dosage of camizestrant from 150mg to 75mg. This change was prompted by updated, emerging data from ongoing studies showing
no difference in efficacy between the 75 mg and 150 mg doses. Subject can expect to be in this study for up to 24 months.
This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.
This phase 3 study is recruiting patients who have myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
The purpose of this study is to evaluate investigational treatments (study drug) in people with subjects with c-Met over-expressed refractory metastatic colorectal cancer
The purpose of this study is to determine the recommended ABBV-400 dose when ABBV-400 is given alone (monotherapy) in Stage 1, and to assess if ABBV-400 monotherapy is a safe and effective treatment compared to the standard of care (SOC) LONSURF [Trifluridine and Tipiracil] plus Bevacizumab in subjects with c-Met overexpressed (level of c-Met protein in your tumor cells is increased) uncontrolled metastatic colorectal cancer in Stage 2 of the study plan.
This is a phase 3 study; ABBV-400 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, anemia, muscle aches, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This study is for patients that have recurrent/persistent endometrial cancer. The investigational drug used in this study is Sacituzumab Govitecan (SG). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The study drug is given to participants through infusion. The primary purpose of the study is to compare the effect of SG relative to treatment of physician's choice (TPC) on progression-free survival (PFS) and on overall survival (OS). Participants can expect to be on this study until their demise.
This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.
This study is for patients who have been diagnosed with grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer. The investigational drug used in this study is ipatasertib. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The marketed drug used in this study is megestrol acetate (MA). Marketed means the drug has been approved by the FDA for sale and use in the United States. The primary purpose of this study is to compare the progression free survival of the combination of ipatasertib with MA to MA alone among women with metastatic grade 1-2 recurrent or metastatic endometrioid endometrial cancer. Patients will be randomized to either of the two treatments. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants orally. Participants can expect to be on this study until disease progression or adverse events prohibit further therapy.
The purpose of this study is to evaluate investigational treatments (study drug) in people with recurrent or metastatic PD-L1-positive, HPV-negative head and neck squamous cell carcinoma without prior treatment. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BCA101. This is a phase 2 study; BCA101 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 5 years. The procedures include taking study drug intravenously, blood and urine samples, and CT scans. Risks include diarrhea, nausea, vomiting, mouth sore, nose bleed, headache, and skin rash. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
The purpose of this study is to determine if patients with heart failure (HF, meaning a weak heart) with left ventricular ejection fraction (LVEF) ≤ 50% and with an abnormal heart beat can benefit from having pacemaker leads placed in a different location in the heart. We know that people with a weak heart and an abnormal heart beat can benefit from having a pacemaker. Participants in this study will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:
A. Pacing the heart from two locations in the left ventricle (lower left chamber of the heart)
B. Pacing the heart from one of two other places in the heart (the "His" or the left bundle branch)
The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other.