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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR SODIUM PHENYLBUTYRATE

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Clinical Trials for Sodium Phenylbutyrate

Trial ID Title Status Sponsor Phase Summary
NCT00004767 Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders Completed Johns Hopkins University Phase 2 OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders Completed National Center for Research Resources (NCRR) Phase 2 OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004871 Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Azacitidine plus phenylbutyrate may help leukemia cells develop into normal white blood cells. PURPOSE: Phase I trial to study the effectiveness of combining azacitidine and phenylbutyrate in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.
NCT00004871 Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed Sidney Kimmel Comprehensive Cancer Center Phase 1 RATIONALE: Azacitidine plus phenylbutyrate may help leukemia cells develop into normal white blood cells. PURPOSE: Phase I trial to study the effectiveness of combining azacitidine and phenylbutyrate in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.
NCT00005639 Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment.
NCT00005639 Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment Completed Sidney Kimmel Comprehensive Cancer Center Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment.
NCT00005934 5-Azacytidine and Phenylbutyrate to Treat Severe Thalassemia Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 This study will evaluate the safety and effectiveness of 5-azacytidine and phenylbutyrate for treating thalassemia major. Patients with this disease have abnormal production of hemoglobin (the oxygen-carrying protein in red blood cells), which leads to red blood cell destruction. As a result, patients require frequent red cell transfusions over many years. Because of these transfusions, however, excess iron is deposited in various body organs-such as the heart, liver, thyroid gland and, in men, the testes-impairing their function. Fetal hemoglobin-a type of hemoglobin that is produced during fetal and infant life-can substitute for adult hemoglobin and increase the levels of red cells in the body. After infancy, however, this type of hemoglobin is no longer produced in large quantities. 5-azacytidine can increase fetal hemoglobin levels, but this drug can damage DNA, which in turn can increase the risk of cancer. This study will try to lessen the harmful effects of 5-azacytidine by using only one or two doses of it, followed by long-term therapy with phenylbutyrate, a drug that may be as effective as 5-azacytidine with less harmful side effects. Patients 18 years of age and older with severe thalassemia major may be eligible for this study. Before beginning treatment, candidates will have a medical history and physical examination, blood tests, chest X-ray, electrocardiogram (EKG), bone marrow biopsy (removal of a small sample of bone marrow from the hip for microscopic examination) and whole-body magnetic resonance imaging (MRI). For the biopsy, the area of the hip is anesthetized and a special needle is inserted to draw bone marrow from the hipbone. For the MRI scan, a strong magnetic field is used to produce images that will identify sites where the body is making red blood cells. During this procedure, the patient lies on a table in a narrow cylinder containing a magnetic field. Earplugs are placed in the ears to muffle the loud thumping sounds the machine makes when the magnetic fields are being switched. An intravenous (IV) catheter (flexible tube inserted into a vein) is placed in a large vein of the patient's neck, chest or arm for infusion of 5-azacytidine at a constant rate over 4 days. Patients who do not respond to this first dose of 5-azacytidine will be given the drug again after about 50 days. If they do not respond to the second dose, alternate treatments will have to be considered. Patients who respond to 5-azacytidine will begin taking phenylbutyrate on the 14th day after 5-azacytidine was started. They will take about 10 large pills 3 times a day, continuing for as long as the treatment is beneficial. All patients will be hospitalized for at least 6 days starting with the beginning of 5-azacytidine therapy. Those who are well enough may then be discharged and continue treatment as an outpatient. Patients will be monitored with blood tests daily for 2 weeks and then will be seen weekly for about another 5 weeks. Bone marrow biopsies will be repeated 6 days after treatment begins and again at 2 weeks and 7 weeks. MRI will be repeated 7 weeks after treatment begins. After 7 weeks, patients will be seen at 3-month intervals. Bone marrow biopsies will be done every 6 months for the first 3 years after treatment. Patients will have red cell transfusions as needed and chelation therapy to remove excess iron.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sodium Phenylbutyrate

Condition Name

Condition Name for Sodium Phenylbutyrate
Intervention Trials
Urea Cycle Disorders 6
Amino Acid Metabolism, Inborn Errors 2
Lymphoma 2
Spinal Muscular Atrophy 2
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Condition MeSH

Condition MeSH for Sodium Phenylbutyrate
Intervention Trials
Urea Cycle Disorders, Inborn 9
Disease 6
Leukemia 4
Preleukemia 4
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Clinical Trial Locations for Sodium Phenylbutyrate

Trials by Country

Trials by Country for Sodium Phenylbutyrate
Location Trials
United States 93
Canada 3
France 2
Italy 1
Brazil 1
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Trials by US State

Trials by US State for Sodium Phenylbutyrate
Location Trials
Texas 11
New York 10
California 8
Pennsylvania 7
Maryland 7
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Clinical Trial Progress for Sodium Phenylbutyrate

Clinical Trial Phase

Clinical Trial Phase for Sodium Phenylbutyrate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Sodium Phenylbutyrate
Clinical Trial Phase Trials
Completed 20
Recruiting 3
Active, not recruiting 2
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Clinical Trial Sponsors for Sodium Phenylbutyrate

Sponsor Name

Sponsor Name for Sodium Phenylbutyrate
Sponsor Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland 6
National Cancer Institute (NCI) 3
Assistance Publique - Hôpitaux de Paris 2
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Sponsor Type

Sponsor Type for Sodium Phenylbutyrate
Sponsor Trials
Other 36
NIH 10
Industry 9
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Colorcon
Fish and Richardson
Chinese Patent Office
Johnson and Johnson
Cerilliant
Boehringer Ingelheim
Argus Health

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