Esophageal Diseases News

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||||||||||  cisplatin / Generic mfg., docetaxel / Generic mfg.
New P2 trial:  Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer (clinicaltrials.gov) -  Jul 12, 2012
P2, N=36, Completed,  Sponsor: Chonnam National University Hospital

|||||||||| Enrollment open: Imaging Study Compare 4DCT Image (clinicaltrials.gov) - Jul 12, 2012
P1, N=36, Recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting

||||||||||  Sutent (sunitinib) / Pfizer
Enrollment closed, Surgery:  Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer (clinicaltrials.gov) -  Jul 11, 2012
P2, N=36, Active, not recruiting,  Sponsor: University Health Network, Toronto
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  Dexilant (dexlansoprazole) / Takeda
New P4 trial:  Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain (clinicaltrials.gov) -  Jul 9, 2012
P4, N=0, Withdrawn,  Sponsor: University of Iowa

|||||||||| Metastases: Nodal Status in Adenocarcinoma of the Esophagus an Cardia (clinicaltrials.gov) - Jul 5, 2012
P=N/A, N=194, Completed, Sponsor: University of Bologna

||||||||||  rabeprazole / Generic mfg.
Enrollment closed, HEOR:  Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis (clinicaltrials.gov) -  Jul 2, 2012
P4, N=3750, Active, not recruiting,  Sponsor: Eisai Co., Ltd.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| Biomarker, Enrollment closed, FDG PET: FDG-PET-CT and Biomarkers in Esophageal Cancer (clinicaltrials.gov) - Jul 2, 2012
P=N/A, N=95, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  BMS-833923 / BMS
Trial initiation date, Combination therapy, Metastases:  A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas (clinicaltrials.gov) -  Jul 1, 2012
P1, N=39, Completed,  Sponsor: Bristol-Myers Squibb
Recruiting --> Active, not recruiting Initiation date: Mar 1956 --> Nov 2009

|||||||||| Clinical: Prevalence of Food Allergies in a Cohort of Adult Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - Jun 27, 2012
P=N/A, N=20, Recruiting, Sponsor: University of South Florida

|||||||||| New P3 trial: To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed (clinicaltrials.gov) - Jun 27, 2012
P3, N=0, Withdrawn, Sponsor: Institute of Liver and Biliary Sciences, India

|||||||||| Trial withdrawal: Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer (clinicaltrials.gov) - Jun 27, 2012
P=N/A, N=0, Withdrawn, Sponsor: Roswell Park Cancer Institute
Initiation date: Mar 1956 --> Nov 2009 Terminated --> Withdrawn

|||||||||| Enrollment change: Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer (clinicaltrials.gov) - Jun 27, 2012
P=N/A, N=0, Withdrawn, Sponsor: Roswell Park Cancer Institute
Terminated --> Withdrawn N=10 --> 0

||||||||||  Takecab (vonoprazan) / Takeda, Phathom Pharma
New P3 trial:  A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis (clinicaltrials.gov) -  Jun 26, 2012
P3, N=19, Completed,  Sponsor: Takeda

||||||||||  fluticasone / Generic mfg., esomeprazole / Generic mfg.
Trial completion:  Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis (clinicaltrials.gov) -  Jun 26, 2012
P=N/A, N=42, Completed,  Sponsor: Walter Reed Army Medical Center
N=10 --> 0 Recruiting --> Completed

||||||||||  pantoprazole / Generic mfg., esomeprazole / Generic mfg.
Trial completion:  PAMES 0109: Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease (clinicaltrials.gov) -  Jun 23, 2012
P3, N=713, Completed,  Sponsor: Takeda
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Biomarker: Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation (clinicaltrials.gov) - Jun 21, 2012
P=N/A, N=100, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center

|||||||||| New P1 trial: Imaging Study Compare 4DCT Image (clinicaltrials.gov) - Jun 20, 2012
P1, N=36, Recruiting, Sponsor: M.D. Anderson Cancer Center

||||||||||  lansoprazole / Generic mfg., esomeprazole / Generic mfg.
Trial termination:  COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI (clinicaltrials.gov) -  Jun 17, 2012
P=N/A, N=25, Terminated,  Sponsor: University of Florida
Active, not recruiting --> Completed Completed --> Terminated; terminated due to enrollment

||||||||||  lansoprazole / Generic mfg., esomeprazole / Generic mfg.
Enrollment change:  COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI (clinicaltrials.gov) -  Jun 17, 2012
P=N/A, N=25, Terminated,  Sponsor: University of Florida
Completed --> Terminated; terminated due to enrollment N=20 --> 25

||||||||||  sunitinib / Generic mfg.
Trial completion, Metastases:  Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction (clinicaltrials.gov) -  Jun 16, 2012
P2, N=98, Completed,  Sponsor: North Central Cancer Treatment Group
N=20 --> 25 Active, not recruiting --> Completed

|||||||||| Trial completion: Exercise for Swallowing Problems After Stroke (clinicaltrials.gov) - Jun 14, 2012
P=N/A, N=200, Completed, Sponsor: Department of Veterans Affairs
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: The Use of International GerdQ Questionnaire (clinicaltrials.gov) - Jun 11, 2012
P=N/A, N=150, Completed, Sponsor: AstraZeneca
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Folotyn (pralatrexate) / Aurobindo
Enrollment closed, Metastases:  Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy (clinicaltrials.gov) -  Jun 11, 2012
P2, N=32, Active, not recruiting,  Sponsor: Ohio State University Comprehensive Cancer Center
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  irinotecan / Generic mfg., gemcitabine / Generic mfg.
Trial completion, Metastases:  S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus (clinicaltrials.gov) -  Jun 11, 2012
P2, N=61, Completed,  Sponsor: Southwest Oncology Group
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion, Combination therapy, Surgery, Metastases:  SAKK 75/06: Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery (clinicaltrials.gov) -  Jun 7, 2012
P1/2, N=27, Completed,  Sponsor: Swiss Group for Clinical Cancer Research
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  varlitinib (ASLAN001) / ASLAN Pharma
New P2 trial, Metastases:  A Clinical Trial Evaluating the Effect of ASLAN001 in Patients With Recurrent/Metastatic Gastric Cancer Whose Tumors Are Either HER-2 Amplified or Co-expressing HER-1 and HER-2 (clinicaltrials.gov) -  Jun 6, 2012
P2, N=24, Completed,  Sponsor: Aslan Pharmaceuticals

||||||||||  ursodeoxycholic acid / Generic mfg.
Enrollment closed:  Clinical Studies on Bile Acids in Barrett's Esophagus (clinicaltrials.gov) -  Jun 6, 2012
P=N/A, N=60, Active, not recruiting,  Sponsor: Department of Veterans Affairs
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  cisplatin / Generic mfg., irinotecan / Generic mfg.
Trial completion, Surgery:  Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer (clinicaltrials.gov) -  Jun 6, 2012
P2/3, N=54, Completed,  Sponsor: University Health Network, Toronto
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Vectibix (panitumumab) / Amgen
Trial completion, Surgery, Metastases:  Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction (clinicaltrials.gov) -  Jun 5, 2012
P2, N=69, Completed,  Sponsor: American College of Surgeons
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  cisplatin / Generic mfg., docetaxel / Generic mfg.
Enrollment change, Surgery, Metastases:  SAKK 76/02: Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) -  Jun 3, 2012
P2, N=21, Completed,  Sponsor: Swiss Group for Clinical Cancer Research
Recruiting --> Completed N=46 --> 21

|||||||||| Enrollment closed: Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients (clinicaltrials.gov) - Jun 3, 2012
P=N/A, N=240, Active, not recruiting, Sponsor: Boston Medical Center
N=46 --> 21 Recruiting --> Active, not recruiting

||||||||||  cisplatin / Generic mfg., docetaxel / Generic mfg.
Trial completion, Surgery, Metastases:  SAKK 75/02: Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer (clinicaltrials.gov) -  Jun 1, 2012
P2, N=66, Completed,  Sponsor: Swiss Group for Clinical Cancer Research
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| New P2 trial: Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer (clinicaltrials.gov) - May 29, 2012
P2, N=170, Recruiting, Sponsor: King Faisal Specialist Hospital & Research Center

||||||||||  Vizimpro (dacomitinib) / Pfizer
New P2 trial, Metastases:  A Phase II Trial of PF-00299804 in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus (clinicaltrials.gov) -  May 28, 2012
P2, N=49, Recruiting,  Sponsor: Yonsei University

|||||||||| Trial completion: To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole (clinicaltrials.gov) - May 23, 2012
P4, N=107, Completed, Sponsor: AstraZeneca
Active, not recruiting --> Completed Not yet recruiting --> Completed

|||||||||| Clinical: Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia (clinicaltrials.gov) - May 22, 2012
P=N/A, N=100, Completed, Sponsor: University of Bologna

||||||||||  oxaliplatin / Generic mfg.
New P2 trial, Metastases:  Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer (clinicaltrials.gov) -  May 22, 2012
P2, N=60, Completed,  Sponsor: Fudan University

|||||||||| New P4 trial: Observational Study (This Means That no Drug is Tested) in Patients Suffering of Gastroesophageal Reflux Disease. (clinicaltrials.gov) - May 16, 2012
P4, N=7964, Completed, Sponsor: Janssen-Cilag International NV

|||||||||| Enrollment open: Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux (clinicaltrials.gov) - May 15, 2012
P3, N=70, Recruiting, Sponsor: TTY Biopharm
Not yet recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  cisplatin / Generic mfg., irinotecan / Generic mfg., celecoxib oral / Generic mfg.
Enrollment change, Metastases:  Irinotecan, Cisplatin, and Radiation Therapy With or Without Celecoxib in Treating Patients With Stage II, Stage III, or Stage IV Esophageal Cancer (clinicaltrials.gov) -  May 15, 2012
P2, N=14, Completed,  Sponsor: UNC Lineberger Comprehensive Cancer Center
Not yet recruiting --> Recruiting N=34 --> 14

||||||||||  cisplatin / Generic mfg., irinotecan / Generic mfg., celecoxib oral / Generic mfg.
Trial completion, Metastases:  Irinotecan, Cisplatin, and Radiation Therapy With or Without Celecoxib in Treating Patients With Stage II, Stage III, or Stage IV Esophageal Cancer (clinicaltrials.gov) -  May 15, 2012
P2, N=14, Completed,  Sponsor: UNC Lineberger Comprehensive Cancer Center
N=34 --> 14 Active, not recruiting --> Completed

||||||||||  netazepide (YF476) / Trio Medicines
New P1 trial:  Effect of Repeated Doses of YF476, Omeprazole and Placebo on Stomach Acidity in Healthy Volunteers (clinicaltrials.gov) -  May 14, 2012
P1, N=49, Completed,  Sponsor: Trio Medicines Ltd.

||||||||||  paclitaxel / Generic mfg.
Trial completion, Metastases:  Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer (clinicaltrials.gov) -  May 14, 2012
P2, N=1, Completed,  Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  netazepide (YF476) / Trio Medicines
New P1 trial:  Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers (clinicaltrials.gov) -  May 10, 2012
P1, N=49, Completed,  Sponsor: Trio Medicines Ltd.

|||||||||| Trial initiation date: Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy (clinicaltrials.gov) - May 8, 2012
P=N/A, N=0, Withdrawn, Sponsor: M.D. Anderson Cancer Center
Active, not recruiting --> Completed Initiation date: Apr 2012 --> Nov 2012

|||||||||| Trial completion: Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (clinicaltrials.gov) - May 8, 2012
P=N/A, N=1000, Completed, Sponsor: AstraZeneca
Initiation date: Apr 2012 --> Nov 2012 Recruiting --> Completed

||||||||||  Photofrin (porfimer sodium) / Advanz Pharma
Trial withdrawal:  Oedisse: Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE) (clinicaltrials.gov) -  May 6, 2012
P3, N=0, Withdrawn,  Sponsor: Pinnacle Biologics Inc.
Recruiting --> Completed Not yet recruiting --> Withdrawn

||||||||||  Photofrin (porfimer sodium) / Advanz Pharma
Trial withdrawal:  CALIPSO: Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes (clinicaltrials.gov) -  May 6, 2012
P=N/A, N=0, Withdrawn,  Sponsor: Pinnacle Biologics Inc.
Not yet recruiting --> Withdrawn Not yet recruiting --> Withdrawn

||||||||||  Photofrin (porfimer sodium) / Advanz Pharma
Enrollment change:  Oedisse: Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE) (clinicaltrials.gov) -  May 6, 2012
P3, N=0, Withdrawn,  Sponsor: Pinnacle Biologics Inc.
Not yet recruiting --> Withdrawn N=75 --> 0

||||||||||  Photofrin (porfimer sodium) / Advanz Pharma
Enrollment change:  CALIPSO: Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes (clinicaltrials.gov) -  May 6, 2012
P=N/A, N=0, Withdrawn,  Sponsor: Pinnacle Biologics Inc.
N=75 --> 0 N=500 --> 0



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