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

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
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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

Mayo Clinic Location	Status	Contact
Eau Claire, Wis.	Closed for enrollment	View complete study & contact information
Rochester, Minn.	Closed for enrollment

A Study Evaluating AMG 424 in Subjects With Multiple Myeloma

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

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A Study Evaluating AMG 424 in Subjects With Multiple 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

Prior clinical experience with CD38-targeting antibodies, including daratumumab, establish this molecule as an important therapeutic target in multiple myeloma. CD38 is a type II transmembrane glycoprotein with both ectoenzymatic and signal transductionfunctions. CD38 dimerization is required for its catalytic activity (Desphande et al, 2017).Dimeric CD38 possesses both ADP ribosyl cyclase and cADPR hydrolyase activities; the former generates cyclic ADP ribose (cADPR) from NAD+ and the latter generates ADPR. CD38-mediated cADPR generation enables calcium release from intracellular stores, leading to a variety of cell type-specific physiological outcomes (Schuber and und, 2004; Lee and Aarhus, 1991). A distinct mode of CD38-dependent signal transduction involved in the regulation of proliferation and survival requires interactions with other cell surface molecules (Deshpande et al, 2017; Deaglio et al, 2007; Konopleva et al, 1998). In B- lymphocytes for example, CD38-dependent signal transduction activity utilizes interactions with CD19 and CD31/PECAM-1, the latter of which is the sole identified ligand for CD38 (Deaglio et al, 2007). Importantly, AMG 424 binding to CD38 on target cells results in redirection of T cell mediated cytotoxicity but should not modulate CD38 enzymatic activity or CD38-dependent signal transduction, based on expected serum concentrations in our proposed dosing scheme and significanty reduced binding affinity compared to a monoclonal antibody that does inhibit CD38 activity (Deckert et al., 2014).For this first-in-human study, relapsed/refractory multiple myeloma has been chosen as the indication for clinical investigation of AMG 424 because of the nearly uniform high expression of CD38 on plasma cells observed at the protein level, using flow cytometry (Lin et al, 2004). Although low level CD38 expression is widespread in different tissue types, including hematopoietic cells, plasma cells express CD38 protein at signficantly higher levels than other cell types (Malavasi et al, 2008 and Section 3 of AMG 424 IB).

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: 19-001187
- Rochester, Minnesota: 19-001187
- Scottsdale/Phoenix, Arizona: 19-001187
NCT ID:
NCT03445663
Sponsor Protocol Number:
20160445

Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

Rochester, MN
- See Details
Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
- 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

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. PURPOSE: This randomized phase I/II trial (Phase I completed) is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works compared to placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.

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

Print study details
Site IRB:
Rochester, Minnesota: 09-002385

NCT ID:
NCT00892177

Sponsor Protocol Number:
N0872

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

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Search Results 5511-5520 of 10868

A Study of the Gala Airway Treatment System for the Treatment of Chronic Bronchitis in the United States

Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

A Study of Using Geometrically Accurate Functional MRI to Enable Personalized Radiotherapy of Glioblastoma

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy

A Study to Establish a Mayo Posture Positivity Power Program (MayoP4) for Active and Aging Individuals in Communities

A Study to Evaluate Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients with Chronic Myeloid Leukemia and Persistently- Detectable Minimal Residual Disease

A Study Evaluating AMG 424 in Subjects With Multiple Myeloma

Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

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