Panitumumab Pediatric Study

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658658
• Other study ID #: 20050252
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2008
• Last updated: October 7, 2015
• Start date: March 2008
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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 </= 33% subject 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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 </= 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.

• Major surgery </= 28 days prior to enrollment.

• 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 </= 30 days prior to enrollment.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Panitumumab Treatment
Panitumumab will be given to all cohorts according to dose and age. Enrollment for subsequent cohorts will be determined according to a safety assessment by a Data Review Team made up of investigators and key members of the Amgen study team

Locations

Country	Name	City	State
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Los Angeles	California
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Portland	Oregon
United States	Research Site	San Francisco	California
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric subjects with solid tumors		Until disease progression	Yes
Secondary	To evaluate the incidence of human anti-panitumumab antibody (HAPA) formation and to preliminarily determine if there is evidence of anti-tumor activity of panitumumab in this patient population		Until disease progression	Yes

External Links

•   AmgenTrials clinical trials website