Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.

Official Title
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An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Conditions
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Tumors, Oncology, Solid Tumors

Intervention / Treatment
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* Drug: panitumumab (ABX-EGF)
* Drug: Panitumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic diagnosis of advanced solid tumors that are refractory to at least 1 standard therapy or for which no standard therapy is available and have not received more than 3 prior treatment regimens (not inclusive of hormonal therapies for breast and prostate cancer subjects) for the advanced solid tumor (tumor must be diagnosed by standard criteria for the specific tumor type) Measurable disease or evaluable (non-measurable) disease per RECIST guidelines (all sites of disease must be evaluated within 28 days before enrollment) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of > 3 months as documented by the investigator If history of other primary cancer, subject will be eligible only if she or he has: Non-melanomatous skin cancer, not requiring treatment Curatively treated cervical carcinoma in situ Other primary solid tumor curatively treated with no known active disease present for the last 5 years and no treatment administered for the last 3 years Man or woman 18 years of age or older Paraffin-embedded tumor tissue (from primary or metastatic tumor tissue) available for immunohistochemistry studies of EGFr expression (biopsy or archived tissue are acceptable). The immunohistochemical EGFr staining and evaluation must be conducted at the designated central laboratory using the DakoCytomation EGFR pharmDXTM kit. Local laboratory EGFr expression is not permitted for the purpose of eligibility in this study Hematologic function, as follows: Absolute neutrophil count (ANC) > 1.5 x 109/L Platelet count > 100 x 109/L Hemoglobin > 8 g/dL Renal function, as follows: o Creatinine < 2.0 mg/dL Hepatic function, as follows: Aspartate aminotransferase (AST) < 3 x ULN (if liver metastases ≤ 5 x ULN) Alanine aminotransferase (ALT) < 3 x ULN (if liver metastases ≤ 5 x ULN) Bilirubin < 2 x ULN Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>6mg/kg of panitumumab administered once every 2 weeks until subjects develop disease progression or are unable to tolerate the study drug | Drug: panitumumab (ABX-EGF)<br>* 6 mg/kg once every 2 weeks<br>|
| Experimental: Cohort 2<br>Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug. | Drug: Panitumumab<br>* 9 mg/kg once every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and PK of 2 dose schedules of panitumumab in subjects with advanced solid tumors, refractory to or with no available standard therapy. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targeted Therapy, Solid tumors, ABX-EGF, panitumumab, EGFr, Immunex, Abgenix, Amgen, Monoclonal Antibody