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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.

The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.

The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%.

A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.

Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information
Rochester, Minn.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

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Site IRB:
- Jacksonville, Florida: 22-011685
- Rochester, Minnesota: 22-011685
- Scottsdale/Phoenix, Arizona: 22-011685
NCT ID:
NCT05607004
Sponsor Protocol Number:
ATOS-Z-201

Regional Prophylactic Vancomycin In Revision Total Knee Replacement

Scottsdale/Phoenix, AZ
- See Details
Regional Prophylactic Vancomycin In Revision Total Knee Replacement
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Closed for enrollment
View complete study & contact information

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Site IRB:
Scottsdale/Phoenix, Arizona: 13-004988

NCT ID:
NCT02020031

Sponsor Protocol Number:
13-004988

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

Apixaban In Preventing Secondary Cancer Related Blood Clots In Cancer Patients Who Have Completed Anticoagulation Therapy

Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, Rochester, MN

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Apixaban In Preventing Secondary Cancer Related Blood Clots In Cancer Patients Who Have Completed Anticoagulation Therapy

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related blood clots in cancer patients who have completed anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the enzymes needed for blood clotting.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Eau Claire, Wis.	Closed for enrollment
Jacksonville, Fla.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 17-007127
- Eau Claire, Wisconsin: 17-007127
- Jacksonville, Florida: 17-007127
- Scottsdale/Phoenix, Arizona: 17-007127
NCT ID:
NCT03080883
Sponsor Protocol Number:
ACCRU-SC-1601

A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that induced genetic variation with PARP inhibition disrupting the tumor microenvironment and increasing neoepitope expression can sensitize tumors to immune checkpoint inhibition. We have developed preliminary data with RNAseq suggesting that potent PARP inhibition is associated with gain of novel mutations in pancreas cell lines, even compared to cisplatin alone, or irinotecan alone. We propose that a combination of PARP inhibition and anti-PD1 therapy has valuable therapeutic potential in pancreatic cancer. HRR deficient pancreatic cancer has largely been defined to date based on mutations in well-established genes such as BRCA1/2 and PALB2. However, more DNA repair associated genes are becoming associated with risk for pancreatic cancer and may well impact tumor phenotype. The goal would be to evaluate the combination of niraparib and TSR-042 in patients with germline or somatic mutations in BRCA1/2 or PALB2.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Closed for enrollment	View complete study & contact information
Rochester, Minn.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment

Print study details

Site IRB:
- Jacksonville, Florida: 18-003525
- Rochester, Minnesota: 18-003525
- Scottsdale/Phoenix, Arizona: 18-003525
NCT ID:
NCT04493060
Sponsor Protocol Number:
MC1841

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information
Rochester, Minn.	Closed for enrollment

Medication Therapy Management To Optimize Care Through Effective Resource Management In Inflammatory Bowel Disease

Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Medication Therapy Management To Optimize Care Through Effective Resource Management In Inflammatory Bowel Disease

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
0
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The management of Inflammatory Bowel Disease (IBD) is complex and time consuming. While Current Procedural Terminology for MTM services are available they are under-utilized given the time constraints placed on practitioners trying to address multiple health care issues during a single visit. There are companies that specialize in patient pharmacy services to improve health care outcomes. Our aim is to utilize these services in a small number of IBD patients to assess effectiveness of such services within a tertiary care practice.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
La Crosse, Wis.	Closed for enrollment	View complete study & contact information
Mankato, Minn.	Closed for enrollment
Rochester, Minn.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment
Eau Claire, Wis.	Closed for enrollment
Jacksonville, Fla.	Closed for enrollment

Print study details

Site IRB:
- La Crosse, Wisconsin: 15-006589
- Mankato, Minnesota: 15-006589
- Rochester, Minnesota: 15-006589
- Scottsdale/Phoenix, Arizona: 15-006589
- Eau Claire, Wisconsin: 15-006589
- Jacksonville, Florida: 15-006589
Sponsor Protocol Number:
15-006589

A Study To Evaluate Pembrolizumab With Standard Therapy To Treat Newly-diagnosed Glioblastoma

Scottsdale/Phoenix, AZ, Rochester, MN
- See Details
A Study To Evaluate Pembrolizumab With Standard Therapy To Treat Newly-diagnosed Glioblastoma
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. Drugs used in the chemotherapy, such as pembrolizumab and temozolomide, 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Closed for enrollment
View complete study & contact information

Rochester, Minn.

Closed for enrollment

Print study details
Site IRB:
Scottsdale/Phoenix, Arizona: 16-002965
Rochester, Minnesota: 16-002965

NCT ID:
NCT03197506

Sponsor Protocol Number:
MC1572

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information
Rochester, Minn.	Closed for enrollment

Olaparib And Onalespib In Treating Patients With Solid Tumors That Are Metastatic Or Cannot Be Removed By Surgery Or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, Or Triple-Negative Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

See Details

Olaparib And Onalespib In Treating Patients With Solid Tumors That Are Metastatic Or Cannot Be Removed By Surgery Or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, Or Triple-Negative Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Closed for enrollment
Jacksonville, Fla.	Closed for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 17-000106
- Scottsdale/Phoenix, Arizona: 17-000106
- Jacksonville, Florida: 17-000106
NCT ID:
NCT02898207
Sponsor Protocol Number:
10031

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Search Results 281-290 of 2433

(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Regional Prophylactic Vancomycin In Revision Total Knee Replacement

Apixaban In Preventing Secondary Cancer Related Blood Clots In Cancer Patients Who Have Completed Anticoagulation Therapy

A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer

A Study To Analyze The Amount Of Antibiotic Absorbed Into Tissues Comparing Two Different Modes Of Administration

Health Benefits Of Pulsed Electromagnetic Field Therapy Using Bioboosti

Safety And Efficacy Of Selonsertib In Adults With Compensated Cirrhosis Due To Nonalcoholic Steatohepatitis (NASH)

Medication Therapy Management To Optimize Care Through Effective Resource Management In Inflammatory Bowel Disease

A Study To Evaluate Pembrolizumab With Standard Therapy To Treat Newly-diagnosed Glioblastoma

Olaparib And Onalespib In Treating Patients With Solid Tumors That Are Metastatic Or Cannot Be Removed By Surgery Or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, Or Triple-Negative Breast Cancer

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