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NCT ID: NCT04572295 Active, not recruiting - Breast Neoplasms Clinical Trials

A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

Start date: October 9, 2020
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the tolerability and safety of E7090 as monotherapy and in combination with other anticancer agents in participants with ER+, HER2- recurrent/metastatic breast cancer and to determine the recommended dose (RD) of E7090 in combination with other anticancer agents for subsequent phase studies.

NCT ID: NCT04571944 Completed - Delirium Clinical Trials

Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

Start date: October 22, 2020
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for reducing the incidence of delirium in Japanese participants who are at high risk of delirium. The primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.

NCT ID: NCT04570631 Active, not recruiting - Multiple Myeloma Clinical Trials

Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma

Start date: November 5, 2020
Phase: Phase 1
Study type: Interventional

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM. Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world. Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

NCT ID: NCT04569084 Terminated - ALS Clinical Trials

Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS

Start date: November 13, 2020
Phase: Phase 3
Study type: Interventional

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:

NCT ID: NCT04568902 Active, not recruiting - Breast Neoplasms Clinical Trials

Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Start date: September 30, 2020
Phase: Phase 1
Study type: Interventional

The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.

NCT ID: NCT04568031 Completed - COVID-19 Clinical Trials

Study of AZD1222 for the Prevention of COVID-19 in Japan

Start date: August 23, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.

NCT ID: NCT04567615 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

Start date: February 4, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

NCT ID: NCT04566601 Completed - Clinical trials for Borderline Personality Disorder

A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

Start date: November 13, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04566380 Recruiting - Pan-tumor Clinical Trials

ONO-4538 Phase II Rollover Study (ONO-4538-98)

Start date: September 10, 2020
Phase: Phase 2
Study type: Interventional

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

NCT ID: NCT04565574 Completed - Clinical trials for Healthy Participants

A Study to Assess the Effect of Food Intake and Drug-drug Interactions of E7090 When Co-administered With Rabeprazole or Rifampin in Healthy Participants

Start date: October 16, 2020
Phase: Phase 1
Study type: Interventional

This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A is to evaluate the effect of food on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole (a gastric acid-reducing agent) on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part C is to evaluate the effects of rifampin (a strong Cytochrome P450 3A [CYP3A] inducer) on pharmacokinetics (PK) of single oral doses of E7090 in healthy participants.