Clinical Trials Logo

Filter by:
NCT ID: NCT03781063 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Breast Cancer

Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Start date: September 20, 2019
Phase: Phase 2
Study type: Interventional

This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).

NCT ID: NCT03780569 Active, not recruiting - Clinical trials for Glioblastoma Multiforme

TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM

Start date: April 27, 2017
Phase: N/A
Study type: Interventional

The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to Radiotherapy/Temozolomide followed by Temozolomide. The device is a portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT03778931 Active, not recruiting - Breast Cancer Clinical Trials

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

EMERALD
Start date: May 10, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

NCT ID: NCT03771898 Active, not recruiting - Clinical trials for Metachromatic Leukodystrophy (MLD)

A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy

EMBOLDEN
Start date: May 13, 2019
Phase: Phase 2
Study type: Interventional

The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to retain the ability to move from place to place. Other aims of the study are to determine the effects of intrathecal administration of SHP611 on movement and speech functions and to learn how well SHP611 injected in the spinal fluid that surrounds the brain and spinal cord is tolerated. Study participants will receive SHP611 for about 2 years with the possibility of an extended treatment period.

NCT ID: NCT03767244 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

PROTEUS
Start date: June 11, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

NCT ID: NCT03765918 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

NCT ID: NCT03755791 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

COSMIC-312
Start date: June 10, 2018
Phase: Phase 3
Study type: Interventional

This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

NCT ID: NCT03754790 Active, not recruiting - Hemophilia Clinical Trials

Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

ATLAS-OLE
Start date: January 9, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: - To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: - Bleeding episodes - Spontaneous bleeding episodes - Joint bleeding episodes - To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age

NCT ID: NCT03748641 Active, not recruiting - Clinical trials for Castration-Resistant Prostatic Cancer

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

MAGNITUDE
Start date: January 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

NCT ID: NCT03740165 Active, not recruiting - Ovarian Cancer Clinical Trials

Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)

Start date: December 18, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.