Clinical Trials Logo

Filter by:
NCT ID: NCT03052725 Terminated - Eosinophils, Asthma Clinical Trials

A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Start date: March 10, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

NCT ID: NCT03052517 Terminated - Asthma Clinical Trials

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

NCT ID: NCT03051035 Terminated - Clinical trials for Advanced Malignant Neoplasm

First-in-Human Study of KO-947 in Non-Hematological Malignancies

Start date: April 6, 2017
Phase: Phase 1
Study type: Interventional

This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity.

NCT ID: NCT03041311 Terminated - Clinical trials for Small Cell Lung Cancer

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC

Start date: June 29, 2017
Phase: Phase 2
Study type: Interventional

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100 patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.

NCT ID: NCT03041116 Terminated - Clinical trials for Pantothenate Kinase-Associated Neurodegeneration

Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants

PKAN
Start date: July 17, 2017
Phase: Phase 3
Study type: Interventional

This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement therapy, was safe and effective in treating participants with PKAN.

NCT ID: NCT03033511 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

MERU
Start date: February 7, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

NCT ID: NCT03028740 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

AURORA
Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.

NCT ID: NCT03026166 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

Start date: March 30, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).

NCT ID: NCT03024996 Terminated - Clinical trials for Renal Cell Carcinoma

A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

IMmotion010
Start date: January 3, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

NCT ID: NCT03023527 Terminated - Multiple Myeloma Clinical Trials

Nivolumab Role in the Treatment of Patients With Refractory or Relapse Multiple Myeloma

Start date: January 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized Phase 1 study evaluating the role of two regimens: A) Nivolumab in combination with Pomalidomide and low dose dexamethasone and B) Nivolumab + Elotuzumab + Pomalidomide + dexamethasone in the treatment of relapse or refractory multiple myeloma patients. The study will be performed in 10 sites in Spain. First, the MTD for the Nivo-Pom-Dex combination will be determined using a 3+3 scheme. Once the MTD has been determined both Regimes (A and B) will be open for full accrual and patients will be included in an alternating way in both regimes simultaneously. In the case that an unacceptable toxicity was seen in the Lead-in phase (Nivolumab + Pomalidomide + low dose dexamethasone), the other phase would not be open. A safety analysis by an internal review committee will be performed once the first six patients included in the regimen B have completed the first two cycles. The main purpose of the study is to analyze the proportion of subjects, with refractory or relapsed multiple myeloma, receiving the combination Nivo-Pom-dex or Nivo-Pom-dex-Elo experience one or more haematological and non haematological SAE (grade 3 or higher). Additionally, other Research Hypothesis: The combination of nivolumab with pomalidomide and dexamethasone will demonstrate adequate safety and tolerability to permit further testing of these combinations in subjects with multiple myeloma. The addition of elotuzumab to nivolumab, pomalidomide and dexamethasone will not change the safety profile. Duration of Study: The study will remain open for enrolment for 15 months (estimated), or until the planned total number of 40 subjects is reached if this happens first. The follow-up of the last recruited patient will be up to 3 years, being the Final analyses performed 1,5 years after the last patient is included. Study Population: Male and female adult patients with Multiple Myeloma in first or subsequent relapses, previously exposed to both a proteasome inhibitor and a IMID (Lenalidomide). Patients may be exposed, relapsed or refractory to Lenalidomide.