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Panitumumab Pediatric Study
This study is currently recruiting participants.
Verified by Amgen, February 2009
First Received: April 10, 2008   Last Updated: February 26, 2009   History of Changes
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00658658
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: Panitumumab Treatment
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Panitumumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children With Solid Tumors

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric subjects with solid tumors [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: January 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Age and Dosing Cohort: Experimental
Each Cohort will be stratified by age and dose; all cohorts will receive panitumumab as open-label treatment
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

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of epidermal growth factor receptor expression and biomarker testing
  • Tumor expressing EGFr by immunohistochemistry.
  • 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.
  • Males of reproductive potential unwilling to use adequate contraception for the duration of the study and for 1 month after the last administration of investigational product.
  • Females of childbearing potential not using adequate contraception for the duration of the study and for 6 months after the last administration of investigational product.
  • Pregnant or breast-feeding.
  • Received investigational therapy or procedure </= 30 days prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658658

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, California
Research Site Recruiting
San Francisco, California, United States
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States
United States, Minnesota
Research Site Recruiting
Minneapolis, Minnesota, United States
United States, New York
Research Site Recruiting
New York, New York, United States
United States, Texas
Research Site Recruiting
Houston, Texas, United States
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20050252
Study First Received: April 10, 2008
Last Updated: February 26, 2009
ClinicalTrials.gov Identifier: NCT00658658     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Amgen:
Pediatric
Solid Tumors
Panitumumab
Dose Limiting Toxicities
Open-label
Single Arm
Phase 1
Interventional
Epidermal Growth Factor

Study placed in the following topic categories:
Mitogens

ClinicalTrials.gov processed this record on May 07, 2009