Recurrence News - LARVOL Sigma

Recurrence

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123 Mechanisms of Action

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||||||||||  EXC 001 / Pfizer
New P2 trial, Surgery:  Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery (clinicaltrials.gov) -  Nov 19, 2012
P2, N=100, Recruiting,  Sponsor: Pfizer

|||||||||| New P1/2 trial: iTEPsein: ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA (clinicaltrials.gov) - Nov 19, 2012
P1/2, N=60, Recruiting, Sponsor: Nantes University Hospital

||||||||||  Litx (talaporfin) / Light Sciences Oncology
Trial completion:  Phase 3 Trial of Litx (clinicaltrials.gov) -  Nov 13, 2012
P3, N=483, Completed,  Sponsor: Light Sciences Oncology
Active, not recruiting --> Completed

|||||||||| Trial completion: Atrial Fibrillation Recurrence in Sleep Apnea (clinicaltrials.gov) - Nov 6, 2012
P=N/A, N=196, Completed, Sponsor: Mayo Clinic
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  ribavirin / Generic mfg.
Enrollment closed, Pre-transplantation, Post-transplantation:  Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant (clinicaltrials.gov) -  Nov 1, 2012
P2, N=50, Active, not recruiting,  Sponsor: Gilead Sciences
Recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  verapamil intralesional / Stada
New P4 trial:  Verapamil vs Steroid to Prevent Keloid Recurrence (clinicaltrials.gov) -  Oct 30, 2012
P4, N=30, Recruiting,  Sponsor: The University of Western Australia

||||||||||  everolimus / Generic mfg.
Enrollment open:  The Impact of Everolimus Based Immunosuppression in the Evolution of Hepatitis C Fibrosis After Liver Transplantation (clinicaltrials.gov) -  Oct 30, 2012
P3, N=40, Recruiting,  Sponsor: Hospital Vall d'Hebron
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  Legalon (silibinin) / Viatris
Trial termination:  Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients (clinicaltrials.gov) -  Oct 29, 2012
P2, N=44, Terminated,  Sponsor: Rottapharm
Not yet recruiting --> Recruiting Recruiting --> Terminated; when a blind review highlighted that at least 43% of patients had a virological response

|||||||||| Clinical: the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma (clinicaltrials.gov) - Oct 28, 2012
P=N/A, N=480, Recruiting, Sponsor: ShenFeng

|||||||||| New P3 trial: Hepatocellular Carcinoma Treated With Iodine-125 Implantation (clinicaltrials.gov) - Oct 28, 2012
P3, N=136, Completed, Sponsor: The Second People's Hospital of GuangDong Province

|||||||||| Trial completion: Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh (clinicaltrials.gov) - Oct 28, 2012
P1, N=80, Completed, Sponsor: Cirujanos la Serena
Recruiting --> Terminated; when a blind review highlighted that at least 43% of patients had a virological response Recruiting --> Completed

|||||||||| Trial termination: New Therapy of Laryngeal Papilloma In Children (clinicaltrials.gov) - Oct 26, 2012
P2, N=1, Terminated, Sponsor: Boston University
Recruiting --> Completed Completed --> Terminated; insufficient resource for recruitment

||||||||||  cixutumumab (IMC A12) / Eli Lilly, Torisel (temsirolimus) / Pfizer
Trial completion:  Cixutumumab and Temsirolimus in Treating Younger Patients With Solid Tumors That Have Recurred or Not Responded to Treatment (clinicaltrials.gov) -  Oct 23, 2012
P1, N=39, Completed,  Sponsor: National Cancer Institute (NCI)
Completed --> Terminated; insufficient resource for recruitment Active, not recruiting --> Completed

|||||||||| Enrollment closed, Metastases: Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Prostate Cancer Patients. (clinicaltrials.gov) - Oct 22, 2012
P=N/A, N=200, Active, not recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  everolimus / Generic mfg.
New P3 trial:  The Impact of Everolimus Based Immunosuppression in the Evolution of Hepatitis C Fibrosis After Liver Transplantation (clinicaltrials.gov) -  Oct 14, 2012
P3, N=40, Recruiting,  Sponsor: Hospital Vall d'Hebron

||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic, Xience (everolimus-eluting stent) / Abbott
Trial completion:  PRODIGY: Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention (clinicaltrials.gov) -  Oct 5, 2012
P4, N=1700, Completed,  Sponsor: Marco Valgimigli
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
New P4 trial:  Cimzia Versus Mesalamine for Crohn's Recurrence (clinicaltrials.gov) -  Sep 30, 2012
P4, N=24, Recruiting,  Sponsor: Milton S. Hershey Medical Center

|||||||||| Trial initiation date, HEOR: Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational (clinicaltrials.gov) - Sep 23, 2012
P=N/A, N=855, Completed, Sponsor: AstraZeneca
Active, not recruiting --> Completed Initiation date: Dec 2011 --> Jun 2012

||||||||||  paclitaxel / Generic mfg.
Trial completion, Surgery, Metastases:  Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva (clinicaltrials.gov) -  Sep 19, 2012
P2, N=31, Completed,  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Initiation date: Dec 2011 --> Jun 2012 Active, not recruiting --> Completed

|||||||||| Trial completion, Combination therapy: Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers and Drug Therapy (clinicaltrials.gov) - Sep 6, 2012
P=N/A, N=263, Completed, Sponsor: German Atrial Fibrillation Network
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Enrollment open: Lamotrigine Phase III Study in Bipolar I Disorder (clinicaltrials.gov) - Sep 5, 2012
P3, N=250, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  Lucentis (ranibizumab) / Roche, Novartis
Trial completion:  Wet AMD Recurrence Rate in Patients Stable on Three Month Ranibizumab Dosing (clinicaltrials.gov) -  Aug 26, 2012
P4, N=44, Completed,  Sponsor: University Health Network, Toronto
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

|||||||||| Clinical: Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ (clinicaltrials.gov) - Aug 20, 2012
P=N/A, N=322, Completed, Sponsor: West China College of Stomatology

||||||||||  ribavirin / Generic mfg.
Enrollment change, Pre-transplantation, Post-transplantation:  Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant (clinicaltrials.gov) -  Aug 15, 2012
P2, N=50, Active, not recruiting,  Sponsor: Gilead Sciences
Not yet recruiting --> Completed N=40 --> 50

|||||||||| Clinical: Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair (clinicaltrials.gov) - Aug 13, 2012
P=N/A, N=6783, Completed, Sponsor: University Hospital Koge

||||||||||  Urocidin (mycobacterium cell wall-DNA complex) / Liminal BioSci
Enrollment change:  Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Aug 12, 2012
P2/3, N=129, Completed,  Sponsor: Endo Pharmaceuticals
N=40 --> 50 N=105 --> 129

||||||||||  Urocidin (mycobacterium cell wall-DNA complex) / Liminal BioSci
Trial completion:  Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Aug 12, 2012
P2/3, N=129, Completed,  Sponsor: Endo Pharmaceuticals
N=105 --> 129 Active, not recruiting --> Completed

||||||||||  Zejula (niraparib) / GSK, J&J
Enrollment change, Combination therapy, Metastases:  Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1) (clinicaltrials.gov) -  Aug 5, 2012
P1, N=19, Completed,  Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed N=54 --> 19

||||||||||  Zejula (niraparib) / GSK, J&J
Trial completion, Combination therapy, Metastases:  Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1) (clinicaltrials.gov) -  Aug 5, 2012
P1, N=19, Completed,  Sponsor: Merck Sharp & Dohme Corp.
N=54 --> 19 Recruiting --> Completed

||||||||||  Dotarem (gadoterate meglumine) / Guerbet
Clinical:  Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer (clinicaltrials.gov) -  Aug 2, 2012
P=N/A, N=200, Recruiting,  Sponsor: Universitaire Ziekenhuizen Leuven

||||||||||  verapamil / Generic mfg.
New P4 trial:  Oral Verapamil in Acute Paroxysmal Supra Ventricular Tachycardia(PSVT) Recurrence Control (clinicaltrials.gov) -  Jul 30, 2012
P4, N=90, Completed,  Sponsor: Tehran University of Medical Sciences

||||||||||  atorvastatin / Generic mfg.
Trial completion:  The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation (clinicaltrials.gov) -  Jul 26, 2012
P4, N=125, Completed,  Sponsor: Mayo Clinic
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Enrollment change: Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas (clinicaltrials.gov) - Jul 25, 2012
P=N/A, N=12, Completed, Sponsor: Dartmouth-Hitchcock Medical Center
Active, not recruiting --> Completed N=24 --> 12

|||||||||| Trial completion: PETREC: Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study (clinicaltrials.gov) - Jul 25, 2012
P=N/A, N=101, Completed, Sponsor: Ontario Clinical Oncology Group (OCOG)
N=24 --> 12 Active, not recruiting --> Completed

||||||||||  valacyclovir / Generic mfg.
Enrollment closed:  Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding (clinicaltrials.gov) -  Jul 24, 2012
P=N/A, N=134, Active, not recruiting,  Sponsor: University of Alabama at Birmingham
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment change, HEOR: Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational (clinicaltrials.gov) - Jul 23, 2012
P=N/A, N=855, Completed, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting N=1700 --> 855

||||||||||  fulvestrant / Generic mfg.
Trial termination:  ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer (clinicaltrials.gov) -  Jul 17, 2012
P3, N=0, Terminated,  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
N=1700 --> 855 Completed --> Terminated; low accrual

||||||||||  Campath (alemtuzumab) / Sanofi
Enrollment closed:  T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies (clinicaltrials.gov) -  Jun 21, 2012
P2, N=250, Active, not recruiting,  Sponsor: University of Chicago
Completed --> Terminated; low accrual Recruiting --> Active, not recruiting

||||||||||  ThermoDox (lyso-thermosensitive liposomal doxorubicin) / Imunon
Enrollment change:  DIGNITY: Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall (clinicaltrials.gov) -  Jun 18, 2012
P1/2, N=20, Recruiting,  Sponsor: Celsion
Recruiting --> Active, not recruiting N=109 --> 20

|||||||||| New P3 trial: TOSCAN: To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation (clinicaltrials.gov) - Jun 18, 2012
P3, N=400, Recruiting, Sponsor: University Hospital Inselspital, Berne

|||||||||| Enrollment closed: ENERGY: Reducing Breast Cancer Recurrence With Weight Loss (clinicaltrials.gov) - Jun 17, 2012
P=N/A, N=800, Active, not recruiting, Sponsor: University of California, San Diego
N=109 --> 20 Recruiting --> Active, not recruiting

||||||||||  tranexamic acid oral / Generic mfg.
Trial initiation date:  Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis (clinicaltrials.gov) -  Jun 12, 2012
P3, N=0, Withdrawn,  Sponsor: Seoul National University Hospital
Recruiting --> Active, not recruiting Initiation date: Sep 2010 --> Jul 2011

|||||||||| Clinical: PROMIS: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (clinicaltrials.gov) - Jun 11, 2012
P=N/A, N=820, Recruiting, Sponsor: Agendia

||||||||||  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
Initiation date: Sep 2010 --> Jul 2011 Active, not recruiting --> Completed

||||||||||  colchicine / Generic mfg.
Trial completion:  Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences (clinicaltrials.gov) -  Jun 5, 2012
P3, N=240, Completed,  Sponsor: Azienda Sanitaria Locale 3, Torino
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: MTC: Medications Development for the Treatment of Cannabis Related Disorders (clinicaltrials.gov) - May 30, 2012
P1, N=63, Completed, Sponsor: University of Virginia
Recruiting --> Completed Recruiting --> Completed

||||||||||  Chantix (varenicline) / Pfizer
Trial completion:  Relapse Prevention With Varenicline (clinicaltrials.gov) -  May 30, 2012
P4, N=120, Completed,  Sponsor: Johns Hopkins University
Recruiting --> Completed Recruiting --> Completed

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Zadaxin (thymalfasin) / SciClone
Trial withdrawal, Combination therapy:  Dendritic Cell Based Therapy for Breast Cancer Patients (clinicaltrials.gov) -  May 29, 2012
P2, N=0, Withdrawn,  Sponsor: Inge Marie Svane
Recruiting --> Completed Active, not recruiting --> Withdrawn

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Zadaxin (thymalfasin) / SciClone
Enrollment change, Combination therapy:  Dendritic Cell Based Therapy for Breast Cancer Patients (clinicaltrials.gov) -  May 29, 2012
P2, N=0, Withdrawn,  Sponsor: Inge Marie Svane
Active, not recruiting --> Withdrawn N=100 --> 0

|||||||||| Surgery: UMBI-REC: Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair (clinicaltrials.gov) - May 28, 2012
P=N/A, N=4847, Completed, Sponsor: Koege Sygehus