Organization
Sumitomo Pharma America
61 clinical trials
2 abstracts
Clinical trial
A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1454Status: Recruiting, Estimated PCD: 2025-09-01
Clinical trial
An Open-Label, Fixed Sequence, Multiple Dose Study of Glucose and Insulin Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic DysregulationStatus: Completed, Estimated PCD: 2023-08-22
Clinical trial
A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With SchizophreniaStatus: Completed, Estimated PCD: 2022-12-30
Clinical trial
A Double-Blind, Randomized, Multiple Dose Study of Weight Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic DysregulationStatus: Completed, Estimated PCD: 2024-02-12
Clinical trial
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Acute Leukemia Patients With and Without Mixed Lineage Leukemia (MLL)-Rearrangement or Nucleophosmin 1 (NPM1) MutationStatus: Recruiting, Estimated PCD: 2025-01-02
Clinical trial
An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic AgentsStatus: Active (not recruiting), Estimated PCD: 2024-07-24
Clinical trial
A Randomized, Open-Label, Single Dose, Cross-over Study of Gastric Emptying Rate: SEP-363856 vs Prior Antipsychotic Standard of Care in Subjects With SchizophreniaStatus: Completed, Estimated PCD: 2023-09-27
Clinical trial
A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety DisorderStatus: Recruiting, Estimated PCD: 2025-02-08
Clinical trial
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With SchizophreniaStatus: Terminated, Estimated PCD: 2023-11-09
Clinical trial
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate SEP-363856 Physical Dependence in Adult Subjects With SchizophreniaStatus: Completed, Estimated PCD: 2024-03-15
Clinical trial
A Phase 1, Randomized, Study in Healthy Volunteers to Assess Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654Status: Completed, Estimated PCD: 2023-08-01
Clinical trial
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic AgentsStatus: , Estimated PCD: 2025-01-10
Clinical trial
A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid TumorsStatus: Terminated, Estimated PCD: 2022-10-19
Clinical trial
A Phase 1 Study of DSP-0390 in Patients With Recurrent High-Grade GliomaStatus: Active (not recruiting), Estimated PCD: 2023-10-10
Clinical trial
A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0184 Administered Once Weekly for 4 Weeks to Patients With Advanced Solid TumorsStatus: Completed, Estimated PCD: 2021-03-08
Clinical trial
A Phase Ib Clinical Study of BBI608 for Adult Patients With Advanced, Refractory Hematologic MalignanciesStatus: Completed, Estimated PCD: 2018-12-14
Clinical trial
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With SchizophreniaStatus: Completed, Estimated PCD: 2023-05-12
Clinical trial
A Phase 1, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-1287 to Patients With Advanced Solid TumorsStatus: Terminated, Estimated PCD: 2024-01-10
Clinical trial
A Phase 2, Open-label, Randomized, Two-stage Clinical Study of Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia Following Treatment With Venetoclax Combination TherapyStatus: Terminated, Estimated PCD: 2021-04-22
Clinical trial
A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal TumorsStatus: Terminated, Estimated PCD: 2017-07-25
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)Status: Completed, Estimated PCD: 2020-04-23
Clinical trial
A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).Status: Completed, Estimated PCD: 2020-04-28
Clinical trial
An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor FluctuationsStatus: Completed, Estimated PCD: 2021-08-11
Clinical trial
A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisStatus: Completed, Estimated PCD: 2020-04-20
Clinical trial
A First-in-Human Phase 1/2 Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0509, a Synthetic Toll-Like Receptor 7 (TLR-7) Agonist, Administered as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Advanced Solid TumorsStatus: Completed, Estimated PCD: 2022-12-20
Clinical trial
A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)Status: Terminated, Estimated PCD: 2023-11-17
Clinical trial
A Phase I Clinical Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced MalignanciesStatus: Completed, Estimated PCD: 2018-08-01
Clinical trial
A Combined Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of TP-0903 in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)Status: Terminated, Estimated PCD: 2020-01-21
Clinical trial
A Phase 1/2, Open-Label Clinical Study To Evaluate Safety And Efficacy Of TP-0184 To Treat Anemia When Administered To Adult Patients With IPSS-R Low Or Intermediate Risk Myelodysplastic SyndromesStatus: Terminated, Estimated PCD: 2021-04-27
Clinical trial
A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid TumorsStatus: Terminated, Estimated PCD: 2020-06-15
Clinical trial
A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients With Advanced Solid TumorsStatus: Completed, Estimated PCD: 2021-03-30
Clinical trial
A Phase Ib/II Clinical Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular CarcinomaStatus: Completed, Estimated PCD: 2019-07-01
Clinical trial
A Phase Ib/II Clinical Study of BBI608 in Combination With Temozolomide for Adult Patients With Recurrent or Progressed GlioblastomaStatus: Completed, Estimated PCD: 2018-10-09
Clinical trial
A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary DiseaseStatus: Completed, Estimated PCD: 2003-03-01
Clinical trial
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy VolunteersStatus: Completed, Estimated PCD: 2018-01-23
Clinical trial
A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction AdenocarcinomaStatus: Completed, Estimated PCD: 2017-09-20
Clinical trial
A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Urologic MalignanciesStatus: Withdrawn, Estimated PCD: 2018-08-01
Clinical trial
A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced MalignanciesStatus: Completed, Estimated PCD: 2021-06-01
Clinical trial
A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid TumorsStatus: Completed, Estimated PCD: 2020-06-01
Clinical trial
A Phase I Clinical Study of BBI608 in Adult Patients With Advanced MalignanciesStatus: Completed, Estimated PCD: 2015-08-06
Clinical trial
An Open-Label Positron Emission Tomography Study to Investigate the Effect of Adjunctive Administration of SEP-363856 on Brain Dopamine Synthesis Capacity Using 18F-DOPA in Adult Subjects With SchizophreniaStatus: Completed, Estimated PCD: 2023-06-06
Clinical trial
A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Hepatobiliary CancerStatus: Completed, Estimated PCD: 2017-12-14
Clinical trial
A Phase 1a / 1b, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients With Advanced Solid TumorsStatus: Completed, Estimated PCD: 2022-06-29
Clinical trial
A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients With Intermediate or High-Risk Primary or Secondary MyelofibrosisStatus: Recruiting, Estimated PCD: 2024-12-01
Clinical trial
A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 ElevationStatus: Terminated, Estimated PCD: 2017-01-02
Clinical trial
A Phase 1, Open-label, Dose-escalation, Safety and Biomarker Prediction of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)Status: Completed, Estimated PCD: 2020-03-20
Clinical trial
A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic AdenocarcinomaStatus: Completed, Estimated PCD: 2020-03-01
Clinical trial
A Randomized, Multicenter, Adaptive Phase 3 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (WIZARD 201G)Status: Completed, Estimated PCD: 2021-08-30
Clinical trial
A Phase Ib/II Clinical Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced CancerStatus: Completed, Estimated PCD: 2019-05-01
Clinical trial
A Phase 1b/2, Open-label Clinical Study to Determine Preliminary Safety and Efficacy of Alvocidib When Administered in Sequence After Decitabine or Azacitidine in Patients With MDSStatus: Terminated, Estimated PCD: 2021-08-16
Clinical trial
A Phase Ib Clinical Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid TumorsStatus: Completed, Estimated PCD: 2019-12-01
Clinical trial
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With SchizophreniaStatus: Completed, Estimated PCD: 2023-06-14
Clinical trial
A Phase Ib Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Metastatic Pancreatic AdenocarcinomaStatus: Completed, Estimated PCD: 2020-06-01
Clinical trial
A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)Status: Terminated, Estimated PCD: 2023-10-18
Clinical trial
A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin ProtocolsStatus: Completed, Estimated PCD: 2021-05-15
Clinical trial
A Phase III Randomized, Open-Label Clinical Trial of BBI-608 Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung CancerStatus: Terminated, Estimated PCD: 2017-04-24
Clinical trial
A Phase Ib/II Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal CancerStatus: Completed, Estimated PCD: 2019-03-01
Clinical trial
A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal CancerStatus: Completed, Estimated PCD: 2018-06-01
Clinical trial
Phase 2, Randomized, Biomarker-driven Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With MCL-1 Dependence ≥30%Status: Terminated, Estimated PCD: 2020-02-12
Clinical trial
An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)Status: Completed, Estimated PCD: 2022-11-08
Clinical trial
A Phase I, Open Label, Single Dose Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male SubjectsStatus: Completed, Estimated PCD: 2018-06-02
Abstract
Interim analysis of clinical data and reasons for initiating relugolix on a cohort of US patients: The OPTYX study.Org: University Hospitals Seidman Cancer Center and Case Western Reserve University, University of California, San Diego Health, Northwestern University Feinberg School of Medicine, Department of Urology, Chicago, IL, Chesapeake Urology, Sumitomo Pharma America,
Abstract
Evaluation of persistence and adherence for oral and injectable androgen deprivation therapies (ADT) in United States (US) patients with prostate cancer (PC).Org: Michigan Institute of Urology, Pfizer Inc., Sumitomo Pharma Switzerland, Analysis Group, Inc., Sumitomo Pharma America,