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25 April
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Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

Posted by Goldberg, Persky & White P.C.

Condition Neoplasms Estimated Enrollment: 15 Age Group: 20 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: 15404 Study First Received: June 26, 2015 Last Updated: March 16, 2017 Estimated Primary Completion Date: May 15, 2017 Primary Outcome Measures: Number of Treatment-emergent Adverse Events (TEAEs) as a measure of safety and tolerability|Intensity of TEAEs acc. to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.03|Cmax (maximum drug concentration in plasma after single dose administration ) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|Cmax,norm (Cmax divided by dose (mg) per kg body weight)...

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25 April
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Trial Of Pembrolizumab And Nintedanib

Posted by Goldberg, Persky & White P.C.

Condition Patients With Any Advanced Solid Tumors. Estimated Enrollment: 18 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment Study ID Numbers: 2015-004511-21|2015/2329 Study First Received: August 2, 2016 Last Updated: August 4, 2016 Estimated Primary Completion Date: July 2021 Primary Outcome Measures: MTD of Nintedanib Sponsors and Collaborators: Gustave Roussy, Cancer Campus, Grand Paris Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT02856425...

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25 April
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Atezolizumab and Bevacizumab in Rare Solid Tumors

Posted by Goldberg, Persky & White P.C.

Condition Malignant Neoplasms of Digestive Organs|Malignant Neoplasms of Lip Oral Cavity and Pharynx|Malignant Neoplasms of Mesothelial and Soft Tissue|Malignant Neoplasms of Respiratory and Intrathoracic Organs Estimated Enrollment: 160 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: 2016-0861|NCI-2017-00501 Study First Received: February 22, 2017 Last Updated: April 19, 2017 Estimated Primary Completion Date: March 2021 Primary Outcome Measures: Overall Response Rate of Atezolizumab in Combination with Bevacizumab|Adverse Events of Atezolizumab in Combination with Bevacizumab Sponsors and Collaborators: M.D. Anderson Cancer Center|Genentech, Inc. Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT03074513...

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25 April
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A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

Posted by Goldberg, Persky & White P.C.

Condition Advanced or Metastatic Solid Tumors Estimated Enrollment: 180 Age Group: 18 Years to 99 Years   (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: M16-074|2016-004205-14 Study First Received: March 2, 2017 Last Updated: March 30, 2017 Estimated Primary Completion Date: February 2019 Primary Outcome Measures: Maximum tolerated dose (MTD) of ABBV-368 when administered as monotherapy or in combination with nivolumab|Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with nivolumab|Maximum observed serum concentration (Cmax) of ABBV-368|Time to Cmax (Tmax) of ABBV-368|Area under the serum concentration-time curve (AUC) of ABBV-368|Terminal phase elimination...

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25 April
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Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

Posted by Goldberg, Persky & White P.C.

Condition Advanced Malignancies|Metastatic Malignancies Estimated Enrollment: 450 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: INCAGN 1876-201 Study First Received: April 19, 2017 Last Updated: April 21, 2017 Estimated Primary Completion Date: January 2020 Primary Outcome Measures: Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)|Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST v1.1)|Phase 1 & Phase 2: Duration of response based...

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25 April
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Safety and Effect of GL-ONC1 Administered IV With or Without Eculizumab Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery

Posted by Goldberg, Persky & White P.C.

Condition Solid Organ Cancers Estimated Enrollment: 36 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment Study ID Numbers: 151060 Study First Received: March 2, 2016 Last Updated: June 17, 2016 Estimated Primary Completion Date: March 2018 Primary Outcome Measures: Number of participants with treatment-related adverse events as defined by CTCAE v4.03.|The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.|The maximum concentration (Cmax) of GL-ONC1 in blood after administration|Level of anti-vaccinia neutralizing antibodies in serum|Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue Sponsors and Collaborators: Kaitlyn Kelly, MD|Genelux...

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25 April
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Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Posted by Goldberg, Persky & White P.C.

Condition Advanced Cancer Estimated Enrollment: 1100 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: 3475-158|2015-002067-41|163196 Study First Received: December 9, 2015 Last Updated: February 23, 2017 Estimated Primary Completion Date: September 2017 Primary Outcome Measures: Objective Response Rate (ORR) Sponsors and Collaborators: Merck Sharp & Dohme Corp. Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT02628067...

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25 April
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A Study of ABBV-181 in Participants With Advanced Solid Tumors

Posted by Goldberg, Persky & White P.C.

Condition Advanced Solid Tumors Estimated Enrollment: 158 Age Group: 18 Years to 99 Years   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: M15-891|2016-002520-89 Study First Received: December 15, 2016 Last Updated: March 21, 2017 Estimated Primary Completion Date: June 2018 Primary Outcome Measures: Number of participants with adverse events|Recommended Phase 2 Dose (RPTD) for ABBV-181|Maximum tolerated dose (MTD) of ABBV-181|Maximum observed serum concentration (Cmax)|Time to Cmax (Tmax)|Area under the serum concentration time curve (AUC)|Terminal half-life (t1/2)|Objective response rate (ORR)|Clinical benefit rate (CBR, defined as CR, PR or SD)|Progression-free survival (PFS)|Duration of objective response (DOR) Sponsors and Collaborators: AbbVie Result Received:...

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25 April
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Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study

Posted by Goldberg, Persky & White P.C.

Condition Diffuse Large B-cell Lymphoma|Follicular Lymphoma|Malignant Rhabdoid Tumors (MRT)|Rhabdoid Tumors of the Kidney (RTK)|Atypical Teratoid Rhabdoid Tumors (ATRT)|Synovial Sarcoma|Epitheliod Sarcoma|Mesothelioma|Advanced Solid Tumors Estimated Enrollment: 300 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: EZH-501 Study First Received: August 5, 2016 Last Updated: September 13, 2016 Estimated Primary Completion Date: December 2023 Primary Outcome Measures: Long-term safety profile of tazemetostat measured by number of AEs and duration of exposure to tazemetostat|The overall survival (OS) Sponsors and Collaborators: Epizyme, Inc. Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT02875548...

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25 April
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CBT-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors

Posted by Goldberg, Persky & White P.C.

Condition Solid Tumor|Advanced Cancer|ColoRectal Cancer|Endometrial Cancer|Gastric Cancer|Hepatocellular Cancer|Nonsmall Cell Lung Cancer|Mesothelioma|Ovarian Cancer|Renal Cancer|Nasopharyngeal Cancer|Esophageal Cancer|Gastroesophageal Junction Adenocarcinoma Estimated Enrollment: 50 Age Group: 18 Years and older   (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: CBT-501-01 Study First Received: January 30, 2017 Last Updated: March 30, 2017 Estimated Primary Completion Date: February 2018 Primary Outcome Measures: Number of participants with treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients with advance solid tumors|Determine the recommended Phase 2 dose and schedule|Area under the plasma concentration versus time curve (AUC)|Maximum plasma concentration|Time...

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