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NCT ID: NCT02740114 Terminated - Gynecologic Cancer Clinical Trials

Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway

Start date: August 31, 2016
Phase: Phase 3
Study type: Interventional

Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine. The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery.

NCT ID: NCT02737202 Terminated - Clinical trials for Pulmonary Lymphangioleiomyomatosis

Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis

SLAM-2
Start date: April 2016
Phase: Phase 2
Study type: Interventional

This study is being done to determine if there is a potential benefit of saracatinib in LAM subjects. Based on the information of this trial, additional clinical development trials will be needed. The study will also test the tolerability of 125 mg of saracatinib given once daily over a 9 month period.

NCT ID: NCT02736188 Terminated - GNE Myopathy Clinical Trials

Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start date: May 2, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.

NCT ID: NCT02735369 Terminated - Clinical trials for Proliferative Diabetic Retinopathy (PDR)

A Study Assessing Efficacy and Safety of OC-10X in the Treatment of PDR

Start date: December 2014
Phase: Phase 2
Study type: Interventional

The present study is intended to evaluate the efficacy and safety of topical OC-10X Ophthalmic Suspension in patients diagnosed with proliferative diabetic retinopathy (level 61, 65, 71, or 75). OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of choroidal neovascularization (CNV). Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without the traditional toxicity and works downstream independently of growth factors. As demonstrated by OcuCure's preclinical data, tubulin inhibition, using OC-10X, may be a promising new approach to the treatment of PDR and AMD. Like AMD, PDR is a major cause of blindness in adults and is also caused by the growth of abnormal blood vessels. Importantly, the Phase I Study found that OC-10X can be safely applied topically in human eyes without adverse ocular or systemic effects. Currently, there are few options for the treatment of PDR. Clinical options, such as laser photocoagulation or vitrectomy, require surgery and can permanently impair patients' vision. With few treatment options available, administration of OC-10X as a topical therapy, along with its novel mechanism, has the potential to provide benefits to patients with ocular diseases associated with angiogenesis.

NCT ID: NCT02734615 Terminated - Clinical trials for Advanced or Metastatic ER+ Breast Cancer

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

Start date: June 14, 2016
Phase: Phase 1
Study type: Interventional

To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.

NCT ID: NCT02732938 Terminated - Clinical trials for Metastatic Pancreatic Ductal Adenocarcinoma

Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients

CCR2i
Start date: May 4, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309 and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.

NCT ID: NCT02731690 Terminated - GNE Myopathy Clinical Trials

A Study to Evaluate the Safety of Aceneuramic Acid Extended Release (Ace-ER; UX001) Tablets in Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy (GNEM) (Also Known as Hereditary Inclusion Body Myopathy [HIBM]) Patients With Severe Ambulatory Impairment

Start date: April 29, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this Phase 2 study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM participants with severe ambulatory impairment.

NCT ID: NCT02730195 Terminated - Clinical trials for Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Pioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic Myeloid Leukemia

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well pioglitazone hydrochloride and tyrosine kinase inhibitor (TKI) therapy works in treating patients with chronic myeloid leukemia (CML) that has come back after a period of improvement (relapsed) after a first TKI discontinuation. TKI may stop the growth of cancer cells by blocking certain enzymes need for cell growth. Although TKI therapies are effective against CML, there are residual cancer cells called leukemia stem cells that are able to hide from TKIs. Pioglitazone is a drug approved by the Food and Drug Administration to treat diabetes and has been shown in laboratory studies to increase CML stem cell death when given together with TKI therapy. Giving pioglitazone with TKI therapy may be effective in treating patients with CML.

NCT ID: NCT02728999 Terminated - Clinical trials for Benign Female Reproductive System Neoplasm

Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?

Start date: June 2013
Phase: N/A
Study type: Interventional

Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital. Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees. Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.

NCT ID: NCT02728700 Terminated - Myelofibrosis Clinical Trials

Sirolimus and Mycophenolate Mofetil in Preventing GVHD in Patients With Hematologic Malignancies Undergoing HSCT

Start date: February 2016
Phase: Phase 1
Study type: Interventional

This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such as sirolimus and mycophenolate mofetil, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be better in preventing graft-versus-host disease.