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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

ConditionNeoplasmsEstimated Enrollment: 15Age Group: 20 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 15404Study First Received: June 26, 2015Last Updated: March 16, 2017Estimated Primary Completion Date: May 15, 2017Primary 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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Trial Of Pembrolizumab And Nintedanib

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

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Atezolizumab and Bevacizumab in Rare Solid Tumors

ConditionMalignant 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 OrgansEstimated Enrollment: 160Age 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: 2016-0861|NCI-2017-00501Study First Received: February 22, 2017Last Updated: April 19, 2017Estimated Primary Completion Date: March 2021Primary Outcome Measures:Overall Response Rate of Atezolizumab in Combination with Bevacizumab|Adverse Events of Atezolizumab in Combination with BevacizumabSponsors and Collaborators:M.D. Anderson Cancer Center|Genentech, Inc.Result Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT03074513...

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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

ConditionAdvanced or Metastatic Solid TumorsEstimated Enrollment: 180Age Group: 18 Years to 99 Years   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: M16-074|2016-004205-14Study First Received: March 2, 2017Last Updated: March 30, 2017Estimated Primary Completion Date: February 2019Primary 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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Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

ConditionAdvanced Malignancies|Metastatic MalignanciesEstimated Enrollment: 450Age 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: INCAGN 1876-201Study First Received: April 19, 2017Last Updated: April 21, 2017Estimated Primary Completion Date: January 2020Primary 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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Safety and Effect of GL-ONC1 Administered IV With or Without Eculizumab Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery

ConditionSolid Organ CancersEstimated Enrollment: 36Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: 151060Study First Received: March 2, 2016Last Updated: June 17, 2016Estimated Primary Completion Date: March 2018Primary 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 tissueSponsors and Collaborators:Kaitlyn Kelly, MD|Genelux...

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

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

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

ConditionAdvanced Solid TumorsEstimated Enrollment: 158Age Group: 18 Years to 99 Years   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: M15-891|2016-002520-89Study First Received: December 15, 2016Last Updated: March 21, 2017Estimated Primary Completion Date: June 2018Primary 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:AbbVieResult Received:...

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

ConditionCarcinoma, Non-Small-Cell Lung|Mesothelioma|Bladder Cancer|Ovarian Cancer|Peritoneal Cancer|Thymoma|Thymus Cancer|Uterine Cervical CancerEstimated Enrollment: 24Age 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: UCCI-EXP-16-01Study First Received: January 13, 2017Last Updated: January 13, 2017Estimated Primary Completion Date: January 2020Primary 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 survivalSponsors and Collaborators:Nagla Karim|University of CincinnatiResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT03023319...

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Chest Wall Motion Analysis in Disease

ConditionMesothelioma|Lung Neoplasms|Surgery|Cystic Fibrosis|Pectus Carinatum|Pectus Excavatum|Empyema, Pleural|Pulmonary Disease, Chronic ObstructiveEstimated Enrollment: 400Age Group: 16 Years and older   (Child, Adult, Senior)Gender: AllStudy Type: ObservationalStudy Design Allocation: Observational Model: Case Control|Time Perspective: ProspectiveStudy ID Numbers: 2010109TSStudy First Received: August 5, 2016Last Updated: November 4, 2016Estimated Primary Completion Date: July 2018Primary Outcome Measures:Change in volume of each thoracoabdominal compartment during breathing|Synchrony of chest wall movementSponsors and Collaborators:Heart of England NHS Trust|University of Birmingham|University of WarwickResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02958683...

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