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Phase IB of Selinexor in Combination With Standard Chemotherapy in Patients With Advanced Malignancies

ConditionAdvanced CancersEstimated Enrollment: 142Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 2014-0640|NCI-2015-00693Study First Received: April 14, 2015Last Updated: March 10, 2017Estimated Primary Completion Date: June 2019Primary Outcome Measures:Maximum Tolerated Dose (MTD)|Disease ControlSponsors and Collaborators:M.D. Anderson Cancer Center|Karyopharm Therapeutics IncResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02419495...

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LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

ConditionTumors With CDK4/6 Pathway ActivationEstimated Enrollment: 106Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: CLEE011XUS03Study First Received: July 9, 2014Last Updated: November 27, 2016Estimated Primary Completion Date: April 2018Primary Outcome Measures:Clinical benefit rate associated with LEE011 treatment|Overall Response (OR) of Partial Response (PR) or greater|Progression Free Survival (PFS)|Overall Survival (OS)|Duration of Response (DOR)|Safety and tolerabilitySponsors and Collaborators:Novartis Pharmaceuticals|NovartisResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02187783...

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Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.

ConditionOncologyEstimated Enrollment: 147Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 15051Study First Received: September 1, 2011Last Updated: February 16, 2017Estimated Primary Completion Date: September 2017Primary Outcome Measures:Number of participants with treatment emergent adverse events|Determination of the Pharmakokinetic profile of BAY94-9343 and its metabolites|Biomarker evaluation: mesothelin plasma and Cytokeratin 18 (CK18) levels|Tumor response: assessment of best response, TTP (time to progression), and PFS (progression free survival) according to RECIST (Response Evaluation Criteria in Solid Tumours) 1.1|Immunogenicity assessment: assessment of anti BAY 94-9343 antibodies|Biomarker evaluation...

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Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

ConditionNon-small Cell Lung Cancer|Small Cell Lung Cancer|Mesothelioma|Esophageal Cancer|Gastric Cancer|Liver Cancer|Pancreatic CancerEstimated Enrollment: 350Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Supportive CareStudy ID Numbers: 10-434Study First Received: July 20, 2011Last Updated: February 2, 2017Estimated Primary Completion Date: April 2016Primary Outcome Measures:Functional Assessment of Cancer Therapy (Quality of life measure)|Hospital Anxiety and Depression Scale (Mood)|Prognostic Understanding|Family Caregiver Quality of Life (SF-36)|Family Caregiver Hospital Anxiety and Depression Scale (Mood)|Family Caregiver Prognostic Understanding|Resource utilization at the end of life (EOL)|Health Care Costs|Code Status Documentation|Coping (Brief Cope)|FACT-Lung|FACT-hepatobiliary and FACT-espophagealSponsors and...

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Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

ConditionEsophageal Carcinoma|Hypopharyngeal Carcinoma|Laryngeal Carcinoma|Lymphoma|Malignant Mesothelioma|Malignant Pleural Effusion|Metastatic Malignant Neoplasm in the Spinal Cord|Non-Small Cell Lung Carcinoma|Sarcoma|Small Cell Lung Carcinoma|Thymic Carcinoma|Thymoma|Thyroid Gland CarcinomaEstimated Enrollment: 50Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double Blind (Participant, Investigator)|Primary Purpose: Supportive CareStudy ID Numbers: MC13C1|NCI-2014-00253|P30CA015083Study First Received: February 12, 2014Last Updated: December 20, 2016Estimated Primary Completion Date: October 2017Primary Outcome Measures:Change in mouth pain using a 0 to 10 numerical analogue scale for mouth pain|Adverse event rates using CTCAE, RTOG and PRO|Change in mouth pain using crossover analysis|Incidence of drowsiness|Incidence of grade 3...

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Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

ConditionLiver Cancer|Anxiety Disorder|Depression|Small Cell Lung Cancer|Extrahepatic Bile Duct Cancer|Malignant Mesothelioma|Pancreatic Cancer|Esophageal Cancer|Gastric Cancer|Non-small Cell Lung CancerEstimated Enrollment: 405Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Supportive CareStudy ID Numbers: A221303|U10CA037447|UG1CA189823|NCI-2014-01943Study First Received: January 23, 2015Last Updated: April 19, 2017Estimated Primary Completion Date: June 2018Primary Outcome Measures:Change in FACT-G scores from baseline to 12 weeks between study arms|Change in QOL on the FACT over time|Rate of depressive symptoms as per Hospital Anxiety and Depression Scale (HADS) at 12 weeks and over time|Rate of anxiety symptoms as per...

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Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer

ConditionBreast Cancer|Colorectal Cancer|Lung Cancer|Malignant Mesothelioma|Prostate Cancer|Psychosocial Effects of Cancer and Its Treatment|Thymoma and Thymic CarcinomaEstimated Enrollment: 332Age Group: 18 Years to 120 Years   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open LabelStudy ID Numbers: FCCC-FCRB-04-002-P|CDR0000464245|NCI-2009-00569|06-803Study First Received: September 6, 2006Last Updated: March 1, 2016Estimated Primary Completion Date: November 2010Primary Outcome Measures:Uptake of recommended actions|Number of sections of the Facing Forward manual read with satisfaction and comprehension|Changes in psychological outcomes from baseline to 8-week follow-upSponsors and Collaborators:Fox Chase Cancer Center|National Cancer Institute (NCI)Result Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT00372840...

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Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

ConditionLung Cancer|Lung Cancer Non-Small Cell Cancer (NSCLC)|Lung Cancer Small Cell Lung Cancer (SCLC)|MesotheliomaEstimated Enrollment: 12Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: DiagnosticStudy ID Numbers: LUN0040|18395Study First Received: August 23, 2010Last Updated: July 7, 2016Estimated Primary Completion Date: July 2016Primary Outcome Measures:- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting|- Feasibility of incorporating primary nodal drainage into radiation therapy planning processSponsors and Collaborators:Stanford UniversityResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT01188486...

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Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling

ConditionCancerEstimated Enrollment: 120Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 117360Study First Received: May 30, 2013Last Updated: April 7, 2017Estimated Primary Completion Date: April 14, 2017Primary Outcome Measures:Rate and severity of adverse events (AEs) as a measure of safety and tolerability|Number of Participants withdrawn due to AEs as measure of safety and tolerability|Dose interruptions and reduction as a measure of safety and tolerability|Treatment duration as a measure of safety and tolerability|Dose limiting toxicity (DLT) as a measure of safety and tolerability|Change from baseline...

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Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

ConditionMalignant Pleural Effusion|Lung Cancer|Mesothelioma|Breast Cancer|Ovarian CancerEstimated Enrollment: 19Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: MpeTK01Study First Received: November 19, 2013Last Updated: December 30, 2016Estimated Primary Completion Date: December 2015Primary Outcome Measures:Safety|Progression-free survival|Overall survivalSponsors and Collaborators:Advantagene, Inc.|University of PennsylvaniaResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT01997190...

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