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

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)...

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...

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...

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...

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...

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...

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...

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:...

25 April

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Cancer Research Repository for Individuals With Cancer Diagnosis, High Risk Individuals, and Individuals With No History of Cancer (Control)

Posted by Goldberg, Persky & White P.C.

25 April

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Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Posted by Goldberg, Persky & White P.C.

Condition Carcinoma, Non-Small-Cell Lung|Mesothelioma|Bladder Cancer|Ovarian Cancer|Peritoneal Cancer|Thymoma|Thymus Cancer|Uterine Cervical Cancer Estimated Enrollment: 24 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: UCCI-EXP-16-01 Study First Received: January 13, 2017 Last Updated: January 13, 2017 Estimated Primary Completion Date: January 2020 Primary Outcome Measures: Dose-limiting toxicity of the combination of bosutinib and pemetrexed|Maximum tolerated dose of the combination of bosutinib and pemetrexed|Adverse events of the combination of bosutinib and pemetrexed|Anti-tumor response rate|Progression-free survival Sponsors and Collaborators: Nagla Karim|University of Cincinnati Result Received: No Study Results Posted Website Link: https://ClinicalTrials.gov/show/NCT03023319...

Archive

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

Trial Of Pembrolizumab And Nintedanib

Atezolizumab and Bevacizumab in Rare Solid Tumors

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

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

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

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

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

Cancer Research Repository for Individuals With Cancer Diagnosis, High Risk Individuals, and Individuals With No History of Cancer (Control)

Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

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