Clinical Trials Logo

Filter by:
NCT ID: NCT04074330 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma

Start date: October 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts. The main aims of the study are: - To check for side effects from treatment with TAK-981 given with rituximab. - To check how much TAK-981 participants can tolerate. - To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment. Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons.

NCT ID: NCT04072016 Terminated - Glaucoma Clinical Trials

Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma

Beacon
Start date: April 29, 2020
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.

NCT ID: NCT04070989 Terminated - Osteoarthritis Clinical Trials

Pinnacle RSA Study

Start date: December 3, 2019
Phase: N/A
Study type: Interventional

The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.

NCT ID: NCT04069260 Terminated - Genetic Disease Clinical Trials

A Phase 2 Study of ELX-02 in Patients With Nephropathic Cystinosis

Start date: August 2, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 in patients with cystinosis with nonsense mutation in at least one allele. Six patients will be enrolled in the trial. The study will comprise of the following periods for each patient: - A screening period of up to 6 weeks - A total treatment period of 4 weeks - A safety follow-up period of 4 weeks after the last treatment Each patient will receive three escalating doses as follows: - Treatment period 1: ELX-02 0.5 mg/kg SC daily for 7 days (total dose not to exceed 3.5 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 47.5 µg*h/mL) - Treatment period 2: ELX-02 1.0 mg/kg SC daily for 7 days (total dose not to exceed 7.0 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 95 µg*h/mL) - Treatment period 3: ELX-02 2.0 mg/kg SC daily for 14 days (total dose not to exceed 14 mg/kg for these two weeks; the daily dose will be individualized to achieve the target weekly exposure of about 190 µg*h/mL)

NCT ID: NCT04069000 Terminated - Child Development Clinical Trials

Mind Up (MindUP) Evaluation With Grade 3 Students

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Mind Up (MindUP) is a mindfulness-based social-emotional learning program for children that has shown promising evidence of effectiveness across several domains (including executive functioning and behavioral symptoms). MindUP has exploded in popularity in recent years, but much of the existing research is limited by sample size, lack of accounting for clustering, or has been conducted by the program developers. In this study we are evaluating MindUP with grade three students (~age 8) in three conditions; students who receive MindUP for the first time (n=~150 in 8-10 classrooms), students have been receiving MindUP since kindergarten (~150 in 8-10 classrooms), and students in comparison classrooms (i.e., no intervention; ~150 students in 8-10 classrooms). Regular classrooms teachers will receive training in trauma-informed approaches and the MindUP program prior to implementing. Students will be assessed in the fall and at the end of the school year using structured rating scales; they will also provide self-report data. In November 2020, students' grade 4 teachers will provide another set of ratings to be used as 6-month follow-up data. The primary outcome is social-emotional learning. Secondary outcomes include executive functioning, academic skills, classroom climate, and self-concept.

NCT ID: NCT04068610 Terminated - Clinical trials for Metastatic Microsatellite-stable Colorectal Cancer

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

Start date: September 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

NCT ID: NCT04068259 Terminated - Healthy Subjects Clinical Trials

Single Ascending Dose Study of PBI-4547 in Healthy Subjects

Start date: September 5, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of PBI-4547 in healthy adult participants.

NCT ID: NCT04067180 Terminated - Clinical trials for Acute Myeloid Leukemia

Randomized Clinical Study Assessing Haplo vs. URD in AML

Start date: November 12, 2019
Phase: N/A
Study type: Interventional

This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the hypothesis that haplo SCT is as good as URD SCT. Background: A haplo-identical family donor is a relative sharing 50% of the human leukocyte antigens (HLA) of the patient. SCT with this type of donor is increasing, and a number of retrospective studies have demonstrated its feasibility, but prospective randomized studies are still lacking. Such studies are necessary to establish the benefits of haplo SCT. For the ≈70% of the patients that lack the 1st choice donor, an HLA-matched sibling, the 2nd choice is an URD at most centers. However, if haplo-identical donors are as good as URDs, this could change. Haplo-identical donors have several advantages. Almost all patients have at least one available haplo-identical donor, while URDs can be difficult to find. It also eliminates the need for time-consuming donor searches, and is considerably less costly. The Study: Patients can be included in the study if they have AML and require SCT, ≥18 years, DO NOT have an HLA-matched sibling donor, and DO have potential haplo-identical family donors AND URDs. After enrollment in the study, the patients are assigned randomly to either haplo SCT or URD SCT. The treatment surrounding the transplantation differs according to the donor type. Patients receiving haplo-identical transplantation are treated with a specified chemotherapy protocol before transplantation and a chemotherapy combined with immunosuppressive drugs after the transplantation to prevent graft-vs. host disease (GVHD). The patients receiving URD SCT will be treated according to the standard protocol at their center. Thus, haplo SCT will be compared to what is currently used in patients without an HLA-identical sibling today. The primary endpoint of this study is graft-vs.-host disease- and relapse free survival two years after study inclusion. This measurement takes into account the side effect that causes the most long-term suffering, graft-vs-host disease, as well as leukemia relapse and thus indicates to what extent the treated patients remain relapse-free and without significant side effects. Secondary end points include relapse-free survival, frequencies of graft-versus-host disease and of infections, and the patients will be followed in the study for five years.

NCT ID: NCT04065841 Terminated - Clinical trials for Non Alcoholic Steatohepatitis (NASH)

Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

ELIVATE
Start date: December 30, 2019
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT04060862 Terminated - Breast Cancer Clinical Trials

A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

IPATunity150
Start date: November 15, 2019
Phase: Phase 3
Study type: Interventional

The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.