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163 Clinical Trials near Golden, CO
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerRGX-314 Gene Therapy for Age-Related Macular Degeneration
Lakewood, Colorado
This trial is testing a new one-time gene therapy called RGX-314 for patients with wet AMD. The goal is to reduce the need for regular treatments by helping the eye produce its own protective proteins. This could make treatment easier and more effective for patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 89
Key Eligibility Criteria
Disqualifiers:Retinal Detachment, Advanced Glaucoma, Others
Must Be Taking:Anti-VEGF
660 Participants Needed
Sacituzumab Govitecan + Pembrolizumab for Triple-Negative Breast Cancer
Lakewood, Colorado
This trial compares the effectiveness of a combination of two drugs, SG and pembrolizumab, in patients with advanced triple-negative breast cancer. SG targets and kills cancer cells with chemotherapy, while pembrolizumab helps the immune system attack the cancer. Pembrolizumab has been shown to improve survival in various cancers, including triple-negative breast cancer, when used alone or in combination with other treatments.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Autoimmune, Others
Must Not Be Taking:Topoisomerase Inhibitors
443 Participants Needed
Capivasertib + Docetaxel for Prostate Cancer
Lakewood, Colorado
This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival and/or the radiographic progression free survival of study participants.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, HIV, Hepatitis, Others
Must Be Taking:Androgen Deprivation Therapy
1035 Participants Needed
Selatogrel for Heart Attack
Golden, Colorado
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Intracranial Bleed, Liver Impairment, Dialysis, Others
Must Not Be Taking:Triple Antithrombotic Therapy
14000 Participants Needed
OPT-302 + Ranibizumab for Age-Related Macular Degeneration
Lakewood, Colorado
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Not Listed
990 Participants Needed
RGX-314 Gene Therapy for Wet Age-Related Macular Degeneration
Lakewood, Colorado
This trial is testing a new one-time gene therapy called RGX-314 for patients with wet AMD. It aims to help the eye make its own medicine to stop harmful blood vessels from causing vision loss. This could reduce the need for regular injections. RGX-314 modifies the retina's cells to create a treatment that may only be needed once.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:50 - 89
Key Eligibility Criteria
Disqualifiers:Retinal Detachment, Advanced Glaucoma, Others
Must Be Taking:Anti-VEGF
630 Participants Needed
TAR-200 + Cetrelimab vs Chemoradiotherapy for Bladder Cancer
Golden, Colorado
This trial is testing a new treatment for bladder cancer that combines a device delivering medication directly to the bladder with a drug that helps the immune system fight cancer. The goal is to see if this combination works better than the usual treatment in keeping the bladder free from cancer events.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Urothelial Carcinoma, Diffuse CIS, CT4b/N1-3/M1 Disease, Others
518 Participants Needed
Niraparib + Abiraterone Acetate and Prednisone for Prostate Cancer
Lakewood, Colorado
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Adrenal Dysfunction, MDS/AML, Others
Must Be Taking:Androgen Deprivation Therapy
696 Participants Needed
Capivasertib + Abiraterone for Prostate Cancer
Lakewood, Colorado
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, Heart Disease, Lung Disease, Others
Must Be Taking:Androgen Deprivation Therapy
1012 Participants Needed
Vitamin D3 + Chemotherapy + Bevacizumab for Colorectal Cancer
Golden, Colorado
This trial is testing if vitamin D3 along with regular cancer drugs and another drug that helps the immune system can better treat colorectal cancer that has spread. Vitamin D3 may help the body use essential minerals, making the cancer drugs more effective. Vitamin D3 has been shown to slow down cancer cell growth and help them mature, and it has been effective in reducing intestinal tumors in animal studies.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hypertension, Heart Failure, Bleeding, Others
Must Not Be Taking:Thiazides, Corticosteroids, Lithium, Others
455 Participants Needed
Venetoclax + Chemotherapy for B-Cell Lymphoma
Golden, Colorado
This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, CNS Involvement, Active Hepatitis, Others
Must Not Be Taking:Strong CYP3A4 Inhibitors, Inducers
363 Participants Needed
Evolocumab for Heart Disease
Golden, Colorado
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50 - 79
Key Eligibility Criteria
Disqualifiers:MI, Stroke, CABG, Others
Must Not Be Taking:Anticoagulants
12301 Participants Needed
Immunotherapy + Cabozantinib for Advanced Kidney Cancer
Golden, Colorado
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Hepatitis B/C, Others
Must Not Be Taking:Immunosuppressants, Coumarin Agents
1175 Participants Needed
Apalutamide + ADT for Prostate Cancer
Lakewood, Colorado
This trial is testing if using apalutamide and hormone therapy around the time of surgery can help men with high-risk prostate cancer by reducing the hormones that help the cancer grow.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Distant Metastasis, Prior Prostate Therapy, Heart Disease, Others
Must Be Taking:Androgen Deprivation Therapy
2517 Participants Needed
This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:65+
Key Eligibility Criteria
Disqualifiers:Heart Failure, Recent Stroke, Others
Must Be Taking:Ibrutinib, Obinutuzumab
465 Participants Needed
Pembrolizumab + BCG for Bladder Cancer
Lakewood, Colorado
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.
The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic UC, Active Autoimmune, Others
Must Be Taking:BCG
1397 Participants Needed
Combination Therapy for Chronic Lymphocytic Leukemia
Golden, Colorado
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib, obinutuzumab, and venetoclax may work better than giving ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Congestive Heart Failure, Hepatitis C, Others
Must Not Be Taking:CYP3A Inhibitors, CYP3A Inducers
720 Participants Needed
Hypofractionated Radiation Therapy for Breast Cancer
Golden, Colorado
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metaplastic Breast Cancer, T4, N3, Others
897 Participants Needed
Cabozantinib for Pancreatic Neuroendocrine Tumors
Golden, Colorado
This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Congestive Heart Failure, Cardiac Arrhythmia, Hypertension, Others
Must Not Be Taking:Warfarin, Strong CYP3A4 Inhibitors
298 Participants Needed
Pembrolizumab for Bladder Cancer
Golden, Colorado
This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Diseases, Hepatitis, Pneumonitis, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
739 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
Nivolumab for Anal Cancer
Golden, Colorado
This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Transplant, Autoimmune Disease, Others
Must Not Be Taking:Immune Checkpoint Inhibitors, Immunosuppressants
344 Participants Needed
Chemotherapy + Bevacizumab + Atezolizumab for Colorectal Cancer
Golden, Colorado
This phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of the tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hypertension, Heart Failure, Autoimmune, Others
Must Not Be Taking:Immunosuppressants, Antibiotics
120 Participants Needed
Pembrolizumab for Triple-Negative Breast Cancer
Golden, Colorado
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Active Autoimmune, Others
Must Not Be Taking:Immunotherapy, Biologic Therapy
1155 Participants Needed
Chemotherapy + Atezolizumab for Colon Cancer
Golden, Colorado
This trial is testing whether adding atezolizumab to standard chemotherapy works better than chemotherapy alone for patients with stage III colon cancer who have a specific genetic defect. The chemotherapy drugs aim to kill cancer cells, while atezolizumab helps the immune system attack the cancer. Researchers hope this combination will improve survival rates and quality of life for these patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Hepatitis B/C, Others
Must Not Be Taking:Corticosteroids, Immunosuppressive Medications
700 Participants Needed
Nivolumab +/- Ipilimumab for Lung Cancer
Golden, Colorado
This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Hepatitis, HIV, Others
Must Not Be Taking:Corticosteroids, Immunosuppressives
275 Participants Needed
Weight Loss Intervention for Breast Cancer Recurrence Prevention
Golden, Colorado
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Severe Cardiovascular, Psychiatric Disorders, Others
Must Be Taking:Hormonal Therapy
3177 Participants Needed
Nivolumab for Non-Small Cell Lung Cancer
Golden, Colorado
This trial studies how well nivolumab works in treating patients with non-small cell lung cancer. Nivolumab is an immunotherapy drug that helps the immune system attack cancer cells. The goal is to see if it can prevent the cancer from coming back. Nivolumab has shown efficacy in treating various malignancies, including non-small cell lung cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Autoimmune Disease, Others
Must Not Be Taking:Immune Checkpoint Inhibitors
903 Participants Needed
Ibrutinib + Stem Cell Transplant for Lymphoma
Golden, Colorado
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active CNS Involvement, Hepatic Impairment, Others
Must Not Be Taking:Strong CYP3A Inhibitors, Strong CYP3A Inducers, HIV Protease Inhibitors, Zidovudine
94 Participants Needed
Afatinib +/− Cetuximab for Non-Small Cell Lung Cancer
Golden, Colorado
This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Interstitial Lung Disease, Cardiovascular Abnormalities, Hepatitis, Others
Must Not Be Taking:EGFR Inhibitors
174 Participants Needed
Enzalutamide + Leuprolide for Prostate Cancer
Golden, Colorado
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Recent Surgery, Others
Must Not Be Taking:Hormonal Therapy, Chemotherapy
1068 Participants Needed
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