Panitumumab Pediatric Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00658658
First received: April 10, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children With Solid Tumors

Resource links provided by NLM:


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: March 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Age and Dosing Cohort
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Los Angeles, California, United States, 90027
Research Site Recruiting
San Francisco, California, United States, 94143
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20010
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60611
United States, Minnesota
Research Site Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Research Site Recruiting
Kansas City, Missouri, United States, 64108
United States, New York
Research Site Recruiting
New York, New York, United States, 10021
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States, 97239-3098
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00658658     History of Changes
Other Study ID Numbers: 20050252
Study First Received: April 10, 2008
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014