Clinical Studies Search

Protocol Summary


Protocol No.
PSHCI-15-087
Prinicipal Investigator
Brown, Valerie
Phase
Phase I/II
Age Group
Both
Scope
National
Secondary Protocol No.
GO29665
Title
A Phase I/II, Multicenter, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Patients with Previously Treated Solid Tumors
Objective
The primary objective for this study is as follows:
1. To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the MTD or the maximum administered dose (MAD) and characterization of dose-limiting toxicities (DLTs).

The PK objective for this study is as follows:
1. To characterize the PK of cobimetinib in children and young adults

The efficacy objective for this study is as follows:
1. To evaluate the anticancer activity of cobimetinib in children and young adults with solid and brain tumors, as measured by objective response rate (ORR), progression-free survival (PFS), duration of objective response (DOR), and OS

DOSE-FINDING OBJECTIVE:
1. To identify a recommended Phase II dose for cobimetinib in pediatric patients on the basis of safety, PK, and efficacy outcome measures.

The exploratory objectives for this study are as follows:
1. To explore the relationship between cobimetinib exposure and changes in levels of pharmacodynamic (PD) biomarkers in children and young adults.

2. To explore non-inherited biomarkers that may be predictive of response to cobimetinib (i.e., predictive biomarkers), may be associated with progression to a more severe disease state (i.e., prognostic biomarkers), acquired resistance to cobimetinib, or susceptibility to developing adverse events, may provide evidence of cobimetinib activity, or may increase the knowledge and understanding of disease biology.

3. To explore inherited biomarkers (i.e., variants in germline DNA) that may be predictive of response to cobimetinib (i.e., predictive biomarkers), may be associated with progression to a more severe disease state (i.e., prognostic biomarkers), acquired resistance to cobimetinib, or susceptibility to developing adverse events, or may increase the knowledge and understanding of disease biology.

4. To explore potential relationships between PK parameters for cobimetinib and other outcome measures (such as safety or efficacy outcome measures).

5. To evaluate tumor characteristics before and after treatment on the basis of available magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.

6. To evaluate the acceptability of the taste of cobimetinib.
Applicable Disease Sites
Brain and Nervous System

Ill-Defined Sites

Melanoma, Skin

Soft Tissue
Status
Open
Participating Institutions
Hershey Medical Center