Clinical trial · Interventional
Panitumumab in Children With Solid Tumors
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children With Solid Tumors
NCT00658658CI-TRIAL-00022224completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study was to evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric patients with solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panitumumab | Biological | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panitumumab
- description
- Participants received panitumumab at planned doses ranging from 2.5 mg/kg weekly (QW) to 9.0 mg/kg every 3 weeks (Q3W) until the patient experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
- interventionNames
- Biological: Panitumumab
Primary outcomes (7)
- measure
- Number of Participants With Dose-limiting Toxicities (DLTs)
- timeFrame
- 28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.
- description
- Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhea, nausea, or vomiting that persisted for at least 5 days despite maximum supportive therapy; • Grade 4 skin or nail toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
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 ≥ lower limit of normal (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 epidermal growth factor receptor (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.
References
Publications (0)
Data not yet available
No reference posted for this study.