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NCT ID: NCT04674683 Recruiting - Clinical trials for Unresectable or Metastatic Melanoma

Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma

Start date: August 12, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level.

NCT ID: NCT04674111 Completed - Clinical trials for Coronary Artery Disease

Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

Vortex-FIH
Start date: September 28, 2021
Phase: N/A
Study type: Interventional

Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)

NCT ID: NCT04672460 Completed - Breast Cancer Clinical Trials

A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

Start date: December 21, 2020
Phase: Phase 1
Study type: Interventional

This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.

NCT ID: NCT04670679 Active, not recruiting - Clinical trials for Advanced or Metastatic Solid Tumors

A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

FLAGSHP-1
Start date: December 15, 2020
Phase: Phase 1
Study type: Interventional

- To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors. - To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. - To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. - To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

NCT ID: NCT04669262 Completed - Healthy Clinical Trials

BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants

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

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants

NCT ID: NCT04669067 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

TL-895 and KRT-232 Study in Acute Myeloid Leukemia

Start date: March 31, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.

NCT ID: NCT04668664 Completed - Liver Cirrhosis Clinical Trials

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

Start date: April 5, 2021
Phase:
Study type: Observational

The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insightâ„¢ in patients with cirrhosis who are referred for an EGD and/or EUS.

NCT ID: NCT04667377 Completed - Obesity Clinical Trials

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

NCT ID: NCT04666610 Recruiting - Clinical trials for Childhood Absence Epilepsy

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

EXPAND
Start date: July 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

NCT ID: NCT04666038 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

BRUIN CLL-321
Start date: March 9, 2021
Phase: Phase 3
Study type: Interventional

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.