Panitumumab Pediatric Study



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 17
Updated:4/21/2016
Start Date:March 2008
End Date:March 2015

Use our guide to learn which trials are right for you!

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

This is an open-label, multi-center, single arm, dose-ranging, phase 1, clinical study.
Panitumumab will be administered by IV infusion to 4-6 subjects per cohort. Three planned
cohorts, stratified by age, will be studied at 100% of the recommended panitumumab dose for
each treatment schedule as defined in adults. Enrollment will start with a 2.5 mg/kg once
weekly administration to the 12 to < 18 year old subjects. Upon demonstration of sufficient
safety additional cohorts will open; a 2.5 mg/kg once weekly administration to the 1 to < 12
year old subjects and a 6.0 mg/kg once every two weeks to the 12 to < 18 year old subjects.
The decision to advance to the next cohort will be based on observance of incidence of a dose limiting toxicity during the evaluation period. Subsequent cohorts of
6.0 mg/kg once every two weeks to the 1 to < 12 year old subjects and 9.0 mg/kg once every
three weeks to both age groups will open once sufficient safety in each cohort is
determined. Subjects may stay on study treatment until disease progression.


Inclusion Criteria:

- Parents or legal guardian signed-written informed consent

- 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.

- Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of
epidermal growth factor receptor expression and biomarker testing

- Central nervous system tumors are allowed

- Presence of measurable or non-measurable disease.

- Life expectancy of >/= 12 weeks.

- Performance status: Karnofsky >/= 60% for 12 to <18 years of age; Lansky play scale
>/= 60% for 1 to < 12 years of age.

- Adequate hematologic function.

- Adequate renal function.

- Adequate hepatic function.

- Magnesium >/= LLN

- Adequate pulmonary function

- All previous therapy-related toxicities must have resolved or return to baseline.

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.

- Prior use of any monoclonal antibodies directly targeting the EGFr. Subjects who have
received prior tyrosine kinase inhibitors such as gefitinib or erlotinib are
eligible.

- Immunotherapy, radiotherapy, or chemotherapy weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin, and 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.

- Major surgery
- Known or suspected history of interstitial lung disease.

- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea.

- Known positive test for human immunodeficiency virus infection, hepatitis C virus,
acute or chronic hepatitis B infection, or any co-morbid disease that would increase
risk of toxicity.

- Females of childbearing potential not using adequate contraception precautions for
the duration of the study treatment and for 2 months after the last administration of
investigational product.

- Pregnant or breast-feeding, or planning to become pregnant during study treatment and
within 2 months after the last administration of investigational product.

- Received investigational therapy or procedure
We found this trial at
11
sites
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials