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


Phase 1
1 Year
17 Years
Open (Enrolling)
Both
Solid Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric subjects with solid tumors

Outcome Time Frame:

Until disease progression

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20050252

NCT ID:

NCT00658658

Start Date:

January 2008

Completion Date:

July 2013

Related Keywords:

  • Solid Tumors
  • Epidermal Growth Factor
  • Pediatric
  • Solid Tumors
  • Panitumumab
  • Dose Limiting Toxicities
  • Open-label
  • Single Arm
  • Phase 1
  • Interventional
  • Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteWashington, District of Columbia  
Research SiteAlexandria, Minnesota  
Research SiteAlbany, New York  
Research SiteBend, Oregon  
Research SiteAbilene, Texas