A study to evaluate the safety of panitumumab and children with solid tumours

• Conditions: Solid Tumours; MedDRA version: 17.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005190-36-Outside-EU/EEA
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-22
• Last Update Posted: 26 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• All parents or legal guardians must provide voluntary, signed-written informed consent before any study-specific procedure is conducted. In addition to providing written informed consent, the assent of the child (if applicable) must also be obtained in accordance with the institutional review board (IRB)/independent ethics committee before
any study-specific procedure is conducted.
• 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.
• Central nervous system (CNS) tumors (primary or metastatic) are allowed.
Note:
Subjects who have received prior radiotherapy for CNS metastases must have a minimum of 4 weeks elapsed since last dose of radiotherapy and be considered medically stable and must be on a stable dose of corticosteroids for a minimum of 2 weeks prior to participation in the study.
• Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of epidermal growth factor receptor (EGFr) expression and biomarker testing (not required for brainstem gliomas, if not available)
• Presence of measurable or non-measurable disease
• Life expectancy of = 12 weeks
• Performance status: Karnofsky = 60% for 12 to < 18 years of age (Appendix M); Lansky play scale = 60% for children 1 to < 12 years of age (Appendix N)
• Adequate hematologic function, as follows:
- Absolute neutrophil count (ANC) = 1.5 x 109/L
- Platelet count = 75 x 109/L
- Hemoglobin = 9 g/dL
• Adequate renal function as follows:
- Serum creatinine = 1.5 x upper limit of normal (ULN) for age
• Adequate hepatic function, as follows:
- Aspartate aminotransferase (AST) = 3 x ULN (= 5 X ULN if liver metastases)
- Alanine aminotransferase (ALT) = 3 x ULN (= 5 X ULN if liver metastases)
- Total bilirubin = 1.5 X ULN
• Magnesium = lower limit of normal
• Adequate pulmonary function, as follows:
- Resting O2 saturation on room air = 92% by pulse oximetry
• All previous therapy-related toxicities must have resolved or returned to baseline
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (or within 6 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 59% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received)
• Prior use of any monoclonal antibodies directly targeting the EGFr. Subjects who have received prior tyrosine kinase inhibitors such as gefitinib (Iressa) or erlotinib (Tarceva) 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 (eg, pneumonitis or pulmonary fibrosis)
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as = CTC grade 2 [CTCAE version 3.0])
• 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified