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NCT ID: NCT02712905 Terminated - Clinical trials for Solid Tumors and Hematologic Malignancy

An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Start date: May 5, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.

NCT ID: NCT02704403 Terminated - Clinical trials for Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

RESOLVE-IT
Start date: March 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

NCT ID: NCT02703753 Terminated - Obesity Clinical Trials

TOP-mums, for a Healthy Start

Start date: July 27, 2016
Phase: N/A
Study type: Interventional

This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.

NCT ID: NCT02703571 Terminated - Clinical trials for Pancreatic Cancer for Phase II

Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Start date: June 29, 2016
Phase: Phase 1
Study type: Interventional

Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.

NCT ID: NCT02703272 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

Start date: July 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

NCT ID: NCT02700763 Terminated - Melanoma Clinical Trials

[18F]Dabrafenib Molecular Imaging in Melanoma Brain Metastasis

Start date: December 6, 2016
Phase: N/A
Study type: Interventional

In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients in this study are diagnosed with advanced melanoma with evidence of brain metastases and are eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients will undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and kinetics in brain metastases. In addition, a static total body PET scan will be performed to visualize whole body distribution and tracer uptake.

NCT ID: NCT02697136 Terminated - Clinical trials for Familial Hypoalphalipoproteinemia

CER-001 Therapy as a Novel Approach to Treat Genetic Orphan Diseases

TANGO
Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.

NCT ID: NCT02689024 Terminated - Anesthesia Clinical Trials

Delirium in Elderly Patients With Trauma of the Hip

DEPTHip
Start date: May 2016
Phase: Phase 4
Study type: Interventional

A broken hip occurs frequently in elderly patients and is often very painful. Side effects of inadequately treated pain as well as the traditional drugs (administered through intravenous catheter) used to treat pain are, among others, a confusional state, called delirium. When pain medication is administered locally, only around the hip joint, pain might be treated more effectively and these side effects could be prevented. This is called a nerve block. The current study evaluates the use of a continuous nerve block throughout the complete hospital admission with a catheter around the hip joint versus the use of traditionally used pain medication administered though an intravenous catheter in elderly patients with a broken hip. Half of all patients will receive the nerve block while in the emergency department and the other half will receive pain medication through the intravenous access.

NCT ID: NCT02685046 Terminated - Colonic Neoplasms Clinical Trials

Imatinib as Pre-operative Anti-Colon Cancer Targeted Therapy

ImPACCT
Start date: April 2016
Phase: Phase 2
Study type: Interventional

In this proof-of-concept trial the investigators will study the effects of imatinib treatment on the biology of mesenchymal-type colon cancers.

NCT ID: NCT02683941 Terminated - Clinical trials for Neuroendocrine Tumors in Lung

Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours

SPINET
Start date: March 6, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours. Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5. The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.