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A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

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

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A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

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 is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part. Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.

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

Print study details

Site IRB:
- Jacksonville, Florida: 25-002444
- Rochester, Minnesota: 25-002444
- Scottsdale/Phoenix, Arizona: 25-002444
NCT ID:
NCT06630806
Sponsor Protocol Number:
TED18162

Fucoidan For Patients With Chemotherapy-Related Fatigue

Scottsdale/Phoenix, AZ
- See Details
Fucoidan For Patients With Chemotherapy-Related Fatigue
- 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 the efficacy of fucoidan vs. placebo in preventing fatigue as assessed by a single-item measure of fatigue (Appendix 1, Linear Analog Scale of Fatigue) at 8 weeks following the initiation of platinum-based doublet/triplet. 
The Fucoidan dose of 400 mg formulation is specifically being made for this trial.  

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
Scottsdale/Phoenix, Arizona: 24-004592

NCT ID:
NCT06855524

Sponsor Protocol Number:
MC231007

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

Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

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

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Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA 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 study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.

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
Scottsdale/Phoenix, Ariz.	Closed for enrollment
Rochester, Minn.	Closed for enrollment

Print study details

Site IRB:
- Jacksonville, Florida: 23-003801
- Scottsdale/Phoenix, Arizona: 23-003801
- Rochester, Minnesota: 23-003801
NCT ID:
NCT05477576
Sponsor Protocol Number:
RYZ101-301

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

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

See Details

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

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 find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. Two different doses of BI 764532 are tested in this study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

Print study details

Site IRB:
- Rochester, Minnesota: 23-011875
- Scottsdale/Phoenix, Arizona: 23-011875
- Jacksonville, Florida: 23-011875
NCT ID:
NCT05882058
Sponsor Protocol Number:
1438-0005

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information

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

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information

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Search Results 411-420 of 11529

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

Fucoidan For Patients With Chemotherapy-Related Fatigue

Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Study Of Trastuzumab Deruxtecan, Pembrolizumab, And Platinum-based Chemotherapy In First-line HER2 Overexpressing Non-small Cell Lung Cancer

Study of the Fully Implanted Acclaim® Cochlear Implant

Evaluation of NSR 7T Magnetic Resonance Imaging Hardware and Software

MC240602

A Study To Investigate The Efficacy And Safety Of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib In Adults With Relapsed/Refractory Mantle Cell Lymphoma

Study Is To Assess The Safety And Tolerability Of VTx-002 In Participants With ALS

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