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Archive

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

Posted by Goldberg, Persky & White P.C.

Condition Advanced Cancers Estimated Enrollment: 142 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: 2014-0640|NCI-2015-00693 Study First Received: April 14, 2015 Last Updated: March 10, 2017 Estimated Primary Completion Date: June 2019 Primary Outcome Measures: Maximum Tolerated Dose (MTD)|Disease Control Sponsors and Collaborators: M.D. Anderson Cancer Center|Karyopharm Therapeutics Inc Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT02419495...

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

Posted by Goldberg, Persky & White P.C.

Condition Tumors With CDK4/6 Pathway Activation Estimated Enrollment: 106 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment Study ID Numbers: CLEE011XUS03 Study First Received: July 9, 2014 Last Updated: November 27, 2016 Estimated Primary Completion Date: April 2018 Primary 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 tolerability Sponsors and Collaborators: Novartis Pharmaceuticals|Novartis Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT02187783...

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

Posted by Goldberg, Persky & White P.C.

Condition Oncology Estimated Enrollment: 147 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: 15051 Study First Received: September 1, 2011 Last Updated: February 16, 2017 Estimated Primary Completion Date: September 2017 Primary 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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25 April
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Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Posted by Goldberg, Persky & White P.C.

Condition Non-small Cell Lung Cancer|Small Cell Lung Cancer|Mesothelioma|Esophageal Cancer|Gastric Cancer|Liver Cancer|Pancreatic Cancer Estimated Enrollment: 350 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Supportive Care Study ID Numbers: 10-434 Study First Received: July 20, 2011 Last Updated: February 2, 2017 Estimated Primary Completion Date: April 2016 Primary 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-espophageal Sponsors and...

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25 April
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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

Posted by Goldberg, Persky & White P.C.

Condition Esophageal 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 Carcinoma Estimated Enrollment: 50 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double Blind (Participant, Investigator)|Primary Purpose: Supportive Care Study ID Numbers: MC13C1|NCI-2014-00253|P30CA015083 Study First Received: February 12, 2014 Last Updated: December 20, 2016 Estimated Primary Completion Date: October 2017 Primary 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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25 April
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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

Posted by Goldberg, Persky & White P.C.

Condition Liver Cancer|Anxiety Disorder|Depression|Small Cell Lung Cancer|Extrahepatic Bile Duct Cancer|Malignant Mesothelioma|Pancreatic Cancer|Esophageal Cancer|Gastric Cancer|Non-small Cell Lung Cancer Estimated Enrollment: 405 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Supportive Care Study ID Numbers: A221303|U10CA037447|UG1CA189823|NCI-2014-01943 Study First Received: January 23, 2015 Last Updated: April 19, 2017 Estimated Primary Completion Date: June 2018 Primary 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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25 April
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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

Posted by Goldberg, Persky & White P.C.

Condition Breast Cancer|Colorectal Cancer|Lung Cancer|Malignant Mesothelioma|Prostate Cancer|Psychosocial Effects of Cancer and Its Treatment|Thymoma and Thymic Carcinoma Estimated Enrollment: 332 Age Group: 18 Years to 120 Years   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label Study ID Numbers: FCCC-FCRB-04-002-P|CDR0000464245|NCI-2009-00569|06-803 Study First Received: September 6, 2006 Last Updated: March 1, 2016 Estimated Primary Completion Date: November 2010 Primary 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-up Sponsors and Collaborators: Fox Chase Cancer Center|National Cancer Institute (NCI) Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT00372840...

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25 April
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Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Posted by Goldberg, Persky & White P.C.

Condition Lung Cancer|Lung Cancer Non-Small Cell Cancer (NSCLC)|Lung Cancer Small Cell Lung Cancer (SCLC)|Mesothelioma Estimated Enrollment: 12 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Diagnostic Study ID Numbers: LUN0040|18395 Study First Received: August 23, 2010 Last Updated: July 7, 2016 Estimated Primary Completion Date: July 2016 Primary 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 process Sponsors and Collaborators: Stanford University Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT01188486...

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25 April
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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

Posted by Goldberg, Persky & White P.C.

Condition Cancer Estimated Enrollment: 120 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: 117360 Study First Received: May 30, 2013 Last Updated: April 7, 2017 Estimated Primary Completion Date: April 14, 2017 Primary 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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25 April
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Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

Posted by Goldberg, Persky & White P.C.

Condition Malignant Pleural Effusion|Lung Cancer|Mesothelioma|Breast Cancer|Ovarian Cancer Estimated Enrollment: 19 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment Study ID Numbers: MpeTK01 Study First Received: November 19, 2013 Last Updated: December 30, 2016 Estimated Primary Completion Date: December 2015 Primary Outcome Measures: Safety|Progression-free survival|Overall survival Sponsors and Collaborators: Advantagene, Inc.|University of Pennsylvania Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT01997190...

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