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Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00091806
Recruitment Status : Completed
First Posted : September 21, 2004
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
Amgen

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

Condition or disease Intervention/treatment Phase
Tumors Oncology Solid Tumors Drug: panitumumab (ABX-EGF) Drug: Panitumumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
Study Start Date : August 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
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)
6 mg/kg once every 2 weeks
Experimental: Cohort 2
Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.
 Drug: Panitumumab
9 mg/kg once every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091806


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00091806    
Other Study ID Numbers: 20030251
First Posted: September 21, 2004    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009
Keywords provided by Amgen:
Targeted Therapy
Solid tumors
ABX-EGF, panitumumab
 EGFr
Immunex, Abgenix, Amgen
Monoclonal Antibody
Additional relevant MeSH terms:
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Neoplasms
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents