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NCT ID: NCT03609047 Active, not recruiting - Clinical trials for Breast Cancer Stage II

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

Appalaches
Start date: June 14, 2019
Phase: Phase 2
Study type: Interventional

Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

NCT ID: NCT03607422 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Start date: July 27, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03606590 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA)

Start date: February 15, 2019
Phase: Phase 2
Study type: Interventional

The study is a prospective, phase II trial single arm, historical control aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L(P) System, in combination with sorafenib in patient with advanced HCC. The device is an experimental, 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: NCT03606577 Active, not recruiting - Multiple Myeloma Clinical Trials

An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients

IFM 2018-04
Start date: July 30, 2019
Phase: Phase 2
Study type: Interventional

According to international guidelines, upfront therapy for transplant eligible myeloma patients should include triplet induction containing proteasome inhibitor and immunomodulatory agent, autologous stem cell transplant, PI+Imid based triplet consolidation and lenalidomide maintenance. Despite this approach, virtually all MM patients experience disease relapse, especially those with High Risk disease defined by adverse cytogenetic abnormalities (i.e. del(17p), or t(14;16) or t(4;14)) detected by FISH and/or SNP arrays. Indeed, HR myeloma is associated with poorer progression free survival and overall survival and frontline therapy should therefore be improved for this subset of HR patients. The primary objective of this prospective multicenter, open label, interventional phase 2 trial is to evaluate the feasibility of an intensive program including quadruplet induction and consolidation, tandem autologous stem cell transplantation and maintenance in newly diagnosed multiple myeloma patients presenting with HR cytogenetic. Quadruplet induction and consolidation include carfilzomib, lenalidomide, dexamethasone and daratumumab. Maintenance will include lenalidomide and daratumumab. Secondary objectives will include efficacy parameters (i.e. response rate, minimal residual disease, safety, progression free survival, overall survival).

NCT ID: NCT03603795 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Study Impact on Outcome of Eltrombopag in Elderly Patients With Acute Myeloid Leukemia Receiving Induction Chemotherapy

EPAG2015
Start date: October 11, 2018
Phase: Phase 2
Study type: Interventional

Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study

NCT ID: NCT03603457 Active, not recruiting - Multiple Sclerosis Clinical Trials

OFSEP High Definition Cohort

OFSEP HD
Start date: July 10, 2018
Phase:
Study type: Observational [Patient Registry]

For neurologists and patients, it appears that one major unmet need, beside of course a cure to multiple sclerosis (MS), is to better appreciate the causal factors of disease progression, and even to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course. The overarching objective of the OFSEP-HD cohort is to determine prognostic factors of the evolution of disability in MS in real life, looking at disease characteristics, care practices potentially modifying the evolution of the disease since MS clinical onset and along specific post-onset landmarks. This general framework leads to study 3 specific research objectives: 1. To identify determinants (socio-demographic characteristics, clinical characteristics, health related quality of life (QoL), changes in classification, and biomarkers) for the progression of MS disease and its consequences; 2. To study the effectiveness of treatments in real life; 3. To merge both determinants and treatments for creating patient-centered prognostic tools for identifying specific subgroups of patients and helping making decision to start, maintain or adapt care management. To achieve these objectives, the OFSEP (The French multiple sclerosis registry) infrastructure, managed under a quality insurance system, offers a unique opportunity for the first time in France to create a large cohort of MS cases, providing high-definition and sequential multimodal data.

NCT ID: NCT03602859 Active, not recruiting - Ovarian Neoplasms Clinical Trials

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

FIRST
Start date: October 11, 2018
Phase: Phase 3
Study type: Interventional

Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated both in the PD-L1 positive and overall population of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

NCT ID: NCT03600883 Active, not recruiting - Clinical trials for KRAS p.G12C Mutant Advanced Solid Tumors

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Start date: August 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT03600441 Active, not recruiting - Follicular Lymphoma Clinical Trials

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

FORERUNNER
Start date: August 27, 2018
Phase: Phase 2
Study type: Interventional

This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.

NCT ID: NCT03599960 Active, not recruiting - Clinical trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Combination Chemotherapy in Patients With Newly Diagnosed BPDCN

LpDessai
Start date: May 2, 2019
Phase: Phase 2
Study type: Interventional

Patients with suspected BPDCN and meeting eligibility criteria will be enrolled in the study. First, BPDCN diagnosis will be confirmed by anatomic pathology (Dr Petrella T, Montreal) and cytologic plus immunophenotyping analysis (Pr Garnache Ottou F, UMR1098 BESANCON). Patients will then receive three 21 days cycles of a combination of chemotherapy (Ida/Metho/L-asp/Dex), followed by an evaluation. Patients with complete response (CR) or complete response with incomplete bone marrow recovery (CRi) will undergo an allo- or auto-SCT and those who are not eligible to the transplantation will have successive 28 days cycles of chemotherapy (Metho/L-asp/Dex). Patients who did not respond to the treatment will be treated by physicians. All patients will be followed for 24 months.