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NCT ID: NCT02856867 Withdrawn - Metastatic Disease Clinical Trials

Nintedanib Plus mFOLFOX6 for Previously Untreated Metastatic Esophagogastric Adenocarcinoma (MEGAN)

MEGAN
Start date: December 2016
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with metastatic disease. Patients will have had no previous chemotherapy for metastatic esophagogastric cancer. Patients will receive nintedanib or placebo in combination with mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression. The primary objective is to test the hypothesis that progression free survival (PFS) is prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in the pooled arms.

NCT ID: NCT02856568 Withdrawn - Clinical trials for Unresectable Extrahepatic Bile Duct Carcinoma

Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma

Start date: May 1, 2017
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of ricolinostat when given together with gemcitabine hydrochloride and cisplatin in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ricolinostat together with gemcitabine hydrochloride and cisplatin may work better in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places.

NCT ID: NCT02856178 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients

SAFEGUARD
Start date: April 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML patients.

NCT ID: NCT02848716 Withdrawn - Clinical trials for Overall Survival Comparison Between the 2 Arms

Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Versus Definitive Chemoradiotherapy

LiLACs
Start date: December 2016
Phase: Phase 3
Study type: Interventional

This is an international, prospective, multicenter and randomized phase III study designed to determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging when compared to radiologic staging.

NCT ID: NCT02842372 Withdrawn - Clinical trials for Acute Graft Versus Host Disease in Skin

Ectoin Dermatitis Cream 7% as First-line Therapy of Acute Skin Graft Versus Host Disease

Start date: December 2015
Phase:
Study type: Observational

This is a non-interventional prospective study to investigate the treatment response to topical application with Ectoin Dermatitis Cream 7% as first-line therapy of grade I acute skin graft-versus-host disease.

NCT ID: NCT02839694 Withdrawn - Melanoma Clinical Trials

Adjuvant Oral Decitabine and Tetrahydrouridine With or Without Celecoxib in People Undergoing Pulmonary Metastasectomy

Start date: July 7, 2016
Phase: Phase 1
Study type: Interventional

Background: Most patients who have surgery for cancer that has metastasized (spread) to the lungs later get more metastases that cannot be treated with surgery or chemotherapy. The drug resistance may be due to DNA changes in cancer cells that activate some genes and turn others off. Researchers want to test a combination of drugs for people with metasteses. Decitabine (DAC) may reverse the DNA changes. Tetrahydrouridine (THU) makes DAC last longer. Celecoxib may slow the progression of cancer. Objectives: To determine a safe dose of DAC and THU by mouth. To see if DAC-THU with or without celecoxib reactivates genes in lung metastases. Eligibility: Adults 18 years and older, with cancer in both lungs that can be treated with surgery. Design: Participants will be screened with: Blood, lung, and heart tests Scans Tests for viruses Pregnancy test Participants will have blood and stool tests. They will have surgery to remove metasteses in 1 lung. About 3 weeks later, they will have lung scans. If the disease is not back, participants will get DAC and THU with or without celecoxib, by mouth for 6 weeks. Participants will have more scans. If the disease is not worse, they will continue the study drugs for 4 more weeks. Participants will have more scans and heart and lung tests. They will have surgery to remove metasteses from the other lung. Participants will have weekly blood and urine tests, plus several blood draws the first 2 days of taking the drugs. Participants will have exams and blood tests before each surgery. Participants will have follow-up visits 1 and 3 months after the second surgery.

NCT ID: NCT02835209 Withdrawn - Clinical trials for Respiratory Distress Syndrome, Newborn

Positioning During SBT in NICU Infants

Start date: November 2017
Phase: N/A
Study type: Observational

Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation. Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors. Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.

NCT ID: NCT02833506 Withdrawn - Clinical trials for Recurrent Ovarian Carcinoma

Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Start date: December 8, 2017
Phase: Phase 1
Study type: Interventional

This phase I clinical trial studies the side effects of sirolimus and NY-ESO-1 protein with MIS416 in treating patients stage II-IV ovarian, fallopian tube, or primary peritoneal cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccine therapy, like Y-ESO-1 protein with MIS416, may strengthen the immune system to find and kill tumor cells. Biological therapies, such as sirolimus, 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 vaccine therapy may work betting in treating patients with ovarian, fallopian tube or primary peritoneal cancer.

NCT ID: NCT02831491 Withdrawn - Clinical trials for Stage IV Non-small Cell Lung Cancer

A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer

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

The main purpose of this study is to evaluate the safety of the study drug ramucirumab in combination with weekly docetaxel in participants with stage IV non-small cell lung cancer (NSCLC) following disease progression after prior platinum-based chemotherapy.

NCT ID: NCT02831179 Withdrawn - Clinical trials for Merkel Cell Carcinoma

Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

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

This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.