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A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors

By April 24, 2017 No Comments

Condition

Advanced Solid Tumors

Estimated Enrollment: 217

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: BP27772|2011-003394-28

Study First Received: December 2, 2011

Last Updated: November 1, 2016

Estimated Primary Completion Date: April 2018

 

Primary Outcome Measures:

Percentage of Participants With Adverse Events|Part 1: Maximum Tolerated Dose (MTD)/Optimal Biological Dose (OBD) of RO5509554 as a Single Agent and in Combination With Paclitaxel|Part 2: Change in Colony Stimulating Factor-1 (CSF-1) Serum Level For Every 2 Weeks (Q2W) Schedule|Part 2: Change in CSF-1 Serum Level For Every 3 Weeks (Q3W) Schedule|Part 2: Change in CSF-1 Serum Level For Initial Q2W Followed by Monthly Maintenance Schedule|Change in Circulating Monocytes Subset in Whole Blood For Q2W Schedule|Change in Circulating Monocytes Subset in Whole Blood For Q3W Schedule|Change in Circulating Monocytes Subset in Whole Blood For Initial Q2W Followed by Monthly Maintenance Schedule|Pharmacokinetics of RO5509554: Area Under the Plasma concentration-Time Curve (AUC) for Q2W Schedule|Pharmacokinetics of RO5509554: AUC for Q3W Schedule|Pharmacokinetics of RO5509554: AUC for Initial Q2W Followed by Monthly Maintenance Schedule|Pharmacokinetics of RO5509554: Maximum Observed Plasma concentration (Cmax) for Q2W Schedule|Pharmacokinetics of RO5509554: Cmax for Q3W Schedule|Pharmacokinetics of RO5509554: Cmax for Initial Q2W Followed by Monthly Maintenance Schedule|Pharmacokinetics of RO5509554: Half-life (t1/2) for Q2W Schedule|Pharmacokinetics of RO5509554: t1/2 for Q3W Schedule|Pharmacokinetics of RO5509554: t1/2 Initial Q2W Followed by Monthly Maintenance Schedule|Pharmacokinetics of RO5509554: Systemic Clearance (CL) for Q2W Schedule|Pharmacokinetics of RO5509554: CL for Q3W Schedule|Pharmacokinetics of RO5509554: CL for Initial Q2W Followed by Monthly Maintenance Schedule|Change in Pharmacodynamic Markers: Dermal Macrophages Expressing CD68/CD163 and Colony Stimulating Factor-1 Receptor (CSF-1R) in Paired Skin Biopsies|Change in Pharmacodynamic Markers: Dermal Macrophages Expressing CD68/CD163 and CSF-1R in Paired Tumor Biopsies|Change in Pharmacodynamic Markers: Tumor associated Macrophages (TAM) expressing Cells in Surrogate/Tumor Tissue (in Paired Tumor Biopsies)|Standard Uptake Value of 18F Fluoro-Deoxy-Glucose (FDG), as Assessed Using Positron Emission Tomography (PET) Imaging|Part 1: Recommended Phase II Dose (RP2D) of RO5509554|Percentage of Participants With Objective Response (OR) Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Percentage of Participants With Clinical Benefit Assessed According to RECIST Version 1.1|Progression Free Survival (PFS) Assessed According to RECIST Version 1.1|Duration of Response Assessed According to RECIST Version 1.1

Sponsors and Collaborators:

Hoffmann-La Roche

Website Link: https://ClinicalTrials.gov/show/NCT01494688

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