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Joint Clinical Trials Office

Do More, Feel Better: Lay-delivered Behavioral Activation in Senior Centers

The purpose of this study is to compare 2 forms of interventions for senior center clients over 60 experiencing symptoms of depression. 

Some participants enrolled in the study will receive 9 weeks of a type of psychotherapy called “Behavioral Activation” as delivered by a Master’s level mental health clinician. “Behavioral Activation” is a psychotherapy aimed at re-engaging participants in activities they once found rewarding and enjoyed but have abandoned after they developed depression.

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal Onset Seizures

The main purpose of this study is to determine if XEN1101 can reduce the seizure frequency and if it is safe to use. XEN1101 has been tested in other studies in epilepsy patients and it was considered to be well-tolerated. It had side effects that are similar to other antiseizure drugs commonly used to help patients with epilepsy.

XEN1101 is considered investigational, which means it is not yet approved by the U.S. Food and Drug Administration (FDA). 

A Two-tiered, Phase II, Rule-based, Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib (TEW-7197) for the Treatment of Anemic Patients with Philadelphia Chromosome-negative Myeloproliferative Neoplasms

Currently, the treatments of anemia in patients with myeloproliferative neoplasms (MPNs) include blood transfusions (receiving red blood cells intravenously to replace the lack of functioning red blood cells), erythropoietin stimulating agents given as injections which will help stimulate red blood cell production in the bone marrow, and sometimes steroids. These interventions are supportive but are often insufficient and temporary as they are not capable of blocking the effects of the cancer cells causing anemia. 
   

A Randomized Double-Blind Placebo-Controlled Phase II Multi-Center Study of Inflammation Modification of Canakinumab to Prevent Leukemic Progression of Clonal Cytopenias of Unknown Significance (CCUS): IMPACT Study

The purpose of this study is to test the benefit and safety of Canakinumab for Clonal Cytopenia of Undetermined Significance (CCUS).

Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors

This study will investigate whether a new experimental treatment, ORM-5029, will be a safe and possibly effective treatment option for patients with solid tumors that have higher levels of a protein called HER2. The study is designed to find a safe and effective dose of ORM-5029.

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic TNBC

The purpose of this study is to determine whether an investigational drug called datopotamab deruxtecan (also known as Dato-DXd) is as good or better at treating locally recurrent inoperable or metastatic triple-negative breast cancer, as compared to a single standard chemotherapy. 

Dato-DXd is an investigational drug, which means it is not yet approved by the U.S. Food and Drug Administration (FDA). The chemotherapy options used in this study are FDA-approved.

Technical Development for Fetal and Neonatal MRI

This study involves the enrollment of two patient populations. For the neonatal population, we aim to develop a more accurate and efficient method for identifying abnormalities in the newborn brain using MRI imaging. MRI is the most advanced technique to examine the newborn brain, and it does not involve radiation unlike x-rays or CT. Participation will involve a 60-minute MRI scan without any sedation or contrast injections as well as approximately 2 hours dedicated to swaddling and feeding your child in preparation for the scan.
   

Assessment of Placental Perfusion and Oxygenation Using Novel MRI Approaches

In PEPERONI (PlacEntal PERfusion and OxygeNation Imaging), we use cutting-edge imaging to monitor how well the placenta works. The placenta, a unique and vital organ, is shared by the mother and her offspring during pregnancy. In this study, we are using advanced magnetic resonance imaging (MRI) methods to assess how the placenta performs essential functions, such as perfusion (blood flow) and oxygenation.

A Pilot Study to Evaluate Feasibility of Intraoperative Gamma Probe Tracing of Meningioma using [Cu64] DOTATATE

The purpose of this research is to evaluate the feasibility of using the radiotracer [Cu64]DOTATATE to detect tumors intraoperatively (during surgery) for patients with meningioma.

[Cu64]DOTATATE is a U.S. Food and Drug Administration (FDA) approved PET (positron emission tomography) radiotracer for the imaging of tumors that have a specific marker on their surface (somatostatin receptor). It has not yet been evaluated on whether it can help assess the extent of tumor removed during surgery.

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases

This study is evaluating the addition of stereotactic radiosurgery (SRS) before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue.