A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children with Solid Tumors

Amgen Inc0 sites36 target enrollmentJanuary 22, 2015

DrugsVectibix 20 mg/ml concentrate for solution for infusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Amgen Inc
Enrollment: 36
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2015

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Amgen Inc

Eligibility Criteria

Inclusion Criteria

•All parents or legal guardians must provide voluntary, signed\-written informed consent before any study\-specific procedure is conducted. In addition to providing written informed consent, the assent of the child (if applicable) must also be obtained in accordance with the institutional review board (IRB)/independent ethics committee before
•any study\-specific procedure is conducted.
•1 to \< 18 years of age
•Histologically or cytologically confirmed solid tumor that has recurred after standard therapy, or for which there is no standard therapy. Subjects with brainstem glioma DO NOT need histologic proof of the diagnosis.
•Central nervous system (CNS) tumors (primary or metastatic) are allowed.
•Subjects who have received prior radiotherapy for CNS metastases must have a minimum of 4 weeks elapsed since last dose of radiotherapy and be considered medically stable and must be on a stable dose of corticosteroids for a minimum of 2 weeks prior to participation in the study.
•Paraffin\-embedded tumor tissue from primary tumor or metastasis for determination of epidermal growth factor receptor (EGFr) expression and biomarker testing (not required for brainstem gliomas, if not available)
•Presence of measurable or non\-measurable disease
•Life expectancy of \= 12 weeks
•Performance status: Karnofsky \= 60% for 12 to \< 18 years of age (Appendix M); Lansky play scale \= 60% for children 1 to \< 12 years of age (Appendix N)

Exclusion Criteria

•Diagnosis of leukemia, non\-Hodgkin’s lymphoma, Hodgkin’s disease, or other hematologic malignancy
•Any prior allogeneic transplant
•Prior autologous bone marrow or peripheral stem cell transplant less than 3 months prior to enrollment
•Substantial radiotherapy to the bone marrow within 6 weeks prior to enrollment (or within 6 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 59% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received)
•Prior use of any monoclonal antibodies directly targeting the EGFr. Subjects who have received prior tyrosine kinase inhibitors such as gefitinib (Iressa) or erlotinib (Tarceva) are eligible.
•Immunotherapy, radiotherapy, or chemotherapy \= 2 weeks prior to enrollment (\= 6 weeks for nitrosoureas, mitomycin\-C, and liposomal doxorubicin, and \= 6 weeks from prior antibody therapy)
•Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy (except for pain control), or any other investigational drug while on this study
•Prior seizures \< 3 months prior to enrollment. Subjects with a history of seizure disorders \= 3 months prior to enrollment must be seizure free and on stable anticonvulsant medication(s) for \= 3 months prior to enrollment.
•Presence of a serious uncontrolled medical disorder
•Dementia, altered mental status, or any other medical condition or disorder that would prohibit the understanding or rendering of assent (if applicable), or ability to comply with study procedures