All Individual Drugs Already Approved

Pivotal Trial

Approved for 30 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Summary:

Background: There is a lot of interest in the function and role of HDL to prevent and mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable effects on HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of statins are being used more commonly in practice based on newer outcomes studies which find greater benefits of the higher doses compared to lower or standard doses. This study is testing FDA approved dosages of two commonly used statin medications.

Design: The study is designed to examine the effects of 80mg simvastatin and 80mg atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort with investigators at the U. of Washington who are able to do more advanced testing of HDL particle functionality. Based on the first 13 patients studied at Indiana University, the effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these concentration changes have on the functionality of the particles however. A meta-analysis of 4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was independently associated with regression of atherosclerosis as measured by intravascular ultrasound.

Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria include interacting medications, pregnancy, baseline hepatic disease or other illnesses which would put patients at increased risk of statin side effects.

Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)

High-Dose Statins for Low HDL Cholesterol

This study is evaluating the effects of two commonly used statins on HDLc concentrations.

You drink more than 2 alcoholic drinks per day on average, which is equivalent to more than 14 drinks per week.

I have a history of severe liver problems.

My bad cholesterol levels are high enough to need treatment, according to national guidelines.

I am taking medication that interacts with Zocor or Lipitor.

I haven't had any recent heart problems or unstable chest pain.

I have a working phone number for follow-ups.

I am allergic to or cannot take atorvastatin or simvastatin.

Atorvastatin

Simvastatin

The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Personalized Adaptive Novel Agents for Breast Cancer

This study is evaluating whether a new drug may help treat breast cancer.

I am fully active or can carry out light work.

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

My tumor's hormone and HER2 status fits the study's specific criteria.

My blood counts and liver/kidney functions are within normal ranges.

My breast tumor is larger than 2.5 cm after a biopsy.

My cancer is at an advanced stage but hasn't spread beyond my lymph nodes above my collarbone.

My breast cancer has been confirmed by a tissue examination.

I am willing to have a biopsy of my breast cancer.

I haven't had chemotherapy or radiation for this cancer before. I may have had bisphosphonate therapy.

My tests show no cancer spread to distant parts of my body.

My heart is healthy with an ejection fraction of 50% or higher.

You have had allergic reactions to similar drugs or medications in the past.

My breast cancer test shows specific MammaPrint and hormone receptor results.

Amcenestrant + Abemaciclib

Amcenestrant + Letrozole

Cemiplimab

Cemiplimab plus REGN3767

Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab

Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab

Pembrolizumab - 4 cycle

Pembrolizumab - 8 cycle

SD-101 + Pembrolizumab

This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.

DCE MRI in Patients With Pancreatic Cancer

DCE MRI for Pancreatic Cancer

This study is evaluating whether DCE MRI can help identify pancreatic cancer.

You have allergies to multiple drugs or have had allergic reactions to intravenous iron replacement products.

I am at high risk for pancreatic cancer due to my family history or genetic condition.

I have been diagnosed with pancreatic cancer and may or may not need chemotherapy before surgery.

I have been diagnosed with or suspected to have a condition related to iron overload.

I have liver disease, heart issues, or bronzing of the skin.

I am HIV-positive and not on antiretroviral therapy.

I cannot have gadolinium-based contrast agents due to health reasons.

I need anesthesia to undergo an MRI scan.

I have never had cancer, pancreatic disease, or a family history of pancreatic cancer.

My kidney function is reduced with a GFR less than 60 ml/min.

I have IPMN and my scans show I need surgery based on symptoms or scan results.

Principal Investigator

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Ferumoxytol

This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive) ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body (advanced). Certain characteristics in the DNA of these patients may affect how well they respond to treatment. Learning how adavosertib affects DNA in tumor cells may help doctors plan effective treatment.

Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Adavosertib Before Surgery for Ovarian Cancer

This study is evaluating whether a drug may help treat advanced ovarian cancer.

You have other cancers that are currently being treated, unless certain exceptions apply.

You have major symptoms from the suspected illness.

You have not received treatment before for a specific type of ovarian, fallopian tube, or peritoneal cancer.

Your blood and other body chemical levels need to be within certain normal ranges.

You are able to perform daily activities without any limitations or with only slight restrictions.

Be careful if you are taking certain medications or herbal supplements that might interact with the study drug.

You need to have a negative pregnancy test within 3 days before starting the study.

You cannot take certain medications because they might interfere with the study drug.

You have advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma based on certain clinical signs.

You have received treatment for ovarian, fallopian tube, or primary peritoneal cancer before.

You have a brain disease that is not stable or being treated.

You need to meet certain heart and heart rhythm requirements.

Adavosertib

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

TAVR for Heart Failure

This study is evaluating whether a surgery which replaces the aortic valve may help treat heart failure.

My heart's right ventricle is not working well.

I am allergic or cannot take clopidogrel, aspirin, or blood thinners if needed.

You have other conditions that make it difficult for you to understand and follow the study requirements.

My doctor expects I have less than 2 years to live because of my cancer or other chronic illness.

I was born with a one or two-leaf aortic valve.

I do not have an active infection, including heart infection.

I am not willing to receive blood transfusions.

You are allergic to contrast dye and cannot be properly treated before using it.

You have been diagnosed with moderate aortic stenosis (AS) by a specialized medical imaging center.

Your heart's pumping ability at rest is less than 50%.

I had a heart artery procedure within the last month.

My heart condition limits my physical activities.

I have been on stable heart failure treatment for at least 1 month.

I have been advised to undergo surgery for a heart valve problem not involving the aorta.

I have had a stroke that left me with some lasting disabilities.

My kidney function is very low or I am on dialysis.

My liver condition is severe (Child-Pugh C).

I am not willing to undergo follow-up tests.

I had a CRT device implanted within the last month.

I have severe leakage in my heart valves.

I was hospitalized for worsening heart failure within the last 2 weeks.

You do not have enough calcification on your aortic valve for a specific type of heart procedure.

I show signs of memory loss or confusion.

You have had surgery to replace your aortic valve with a mechanical or bioprosthetic valve in the past.

I have severe lung disease or need daily oxygen support.

My body is suitable for a specific heart valve replacement through my thigh.

I have not had any GI bleeding in the last 3 months.

SAPIEN 3 THV

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Ibrutinib + Rituximab for Follicular Lymphoma

This study is evaluating whether a drug called ibrutinib may help treat lymphoma.

My liver and kidney functions are within normal ranges.

I have a serious heart condition that is currently causing symptoms.

I am 70 or older, or I am 60-69 with one or more health conditions.

I can take care of myself and am up and about more than half of my waking hours.

I have received treatment for follicular lymphoma before.

My cancer affects my brain or spinal cord.

My lymphoma is confirmed to be a type that affects the immune system and is at an advanced stage.

My blood test results are within the required range.

My lymphoma has changed into a more aggressive form.

Ibrutinib

Placebo to match Ibrutinib

Rituximab

This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

DCC-3014 for Giant Cell Tumor

This study is evaluating whether a drug may help treat patients with malignant solid tumors and tenosynovial giant cell tumor.

I have received cancer treatment, including trials, within the specified time before starting the study drug.

I do not have HIV, hepatitis B, hepatitis C, or tuberculosis.

I am not pregnant and agree to use birth control during the study.

I have a condition that affects how my body absorbs medication taken by mouth.

I haven't had major surgery recently before starting the study drug.

I have an advanced tumor or TGCT that cannot be removed by surgery.

I have had blood clots in my arteries or veins.

I haven't had treatments targeting CSF1/CSF1R, drug-related liver issues, or recent TGCT therapy.

I have a solid tumor and can perform all my daily activities without help.

I have been treated with anti-CSF1 or anti-CSF1R therapy before, but not with imatinib or nilotinib.

My organs and bone marrow are functioning well.

I am currently taking proton-pump inhibitors.

I have not had major surgery within the specified timeframe before starting the study drug.

I have symptomatic TGCT and cannot undergo surgery for it.

I do not have active liver or biliary disease.

I can provide a sample of my tumor for the study.

I have metastatic TGCT or another cancer needing treatment now.

I do not have conditions affecting how my body absorbs medication.

My heart's electrical activity (QTcF) is within normal range and I don't have a history of long QT syndrome.

I have side effects from cancer treatment that haven't gone away, except for hair loss.

DCC-3014

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Abemaciclib + Endocrine Therapy for Breast Cancer

This study is evaluating whether a drug can be used to treat breast cancer.

My cancer has spread to distant areas or is present without lymph node involvement.

I have mostly recovered from the side effects of my cancer treatments and surgery.

I am fully active and can carry on all pre-disease activities without restriction.

I am currently on hormone therapy for reproductive reasons.

My cancer is aggressive, scoring 8 or more on a specific scale.

I had breast cancer or other cancers, but have been in remission for over 5 years, except for skin cancer or cervical carcinoma in situ.

My breast cancer has spread to lymph nodes and shows high risk of coming back due to its size, grade, or growth rate.

I had my breast cancer surgery less than 16 months ago.

I do not have any active infections or high viral loads.

I can have hormone therapy for up to 12 weeks after my last cancer treatment.

I have had surgery to remove my breast cancer.

My breast cancer is HR positive, HER2 negative, early stage, and has not spread far.

I can provide tumor tissue from my breast or lymph node for testing before being assigned to a treatment group.

I have been treated with CDK4/6 inhibitors before.

I have taken medication (like tamoxifen) for breast cancer prevention.

I may have hormone therapy for up to 12 weeks after my last cancer treatment.

I have a history of fainting due to heart issues, abnormal heart rhythms, or sudden cardiac arrest. I also have a history of blood clots in my veins.

Abemaciclib

Standard Adjuvant Endocrine Therapy

This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.

Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

MRI with Gadolinium + Ferumoxytol for Brain Conditions

This study is evaluating whether gadolinium and ferumoxytol MRI can help diagnose patients with abnormalities in the central nervous system.

I do not have severe brain symptoms like sudden pupil changes, quick muscle weakness, or fast drops in alertness.

I have experienced neurological symptoms like headaches or seizures.

I do not have genetic hemochromatosis or it has been ruled out with normal TS and SF tests.

I have cancer that might be affecting my brain.

I can have an MRI scan without needing to be put to sleep.

I am using or will use effective birth control during and for two months after the study.

I have not taken ferumoxytol in the last 3 weeks.

Gadolinium

Magnetic Resonance Imaging

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Subcutaneous Daratumumab for High-Risk Smoldering Multiple Myeloma

This study is evaluating whether a drug called daratumumab can prolong progression-free survival in people with smoldering multiple myeloma.

You have more than one small spot in your body that is bigger than 5 millimeters when checked with MRI.

My kidney function is low, not due to multiple myeloma.

I have previously received treatments for SMM or MM, but I am on stable doses of medication for bone health.

I have anemia but haven't received blood transfusions or erythropoietin treatment.

I have previously been treated with daratumumab or other anti-CD38 therapies.

I have been diagnosed with a high-risk type of early-stage multiple myeloma within the last 5 years.

If you are a woman who could become pregnant, you need to have a negative pregnancy test within 14 days before starting the study.

I have multiple myeloma with bone damage or old bone injuries.

My calcium levels are higher than normal, but it's not due to multiple myeloma.

OHSU Clinical Trials 2022

Trials at this site

DCC-3014 for Giant Cell Tumor

Is this your site?

Is this your site?