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Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
This study has been completed.
Study NCT00091806   Information provided by Amgen
First Received: September 17, 2004   Last Updated: July 31, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

September 17, 2004
July 31, 2008
August 2004
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00091806 on ClinicalTrials.gov Archive Site
To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
 
Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

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

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
  • Tumors
  • Oncology
  • Solid Tumors
  • Drug: panitumumab (ABX-EGF)
  • Drug: Panitumumab
  • Experimental: 6mg/kg of panitumumab administered once every 2 weeks until subjects develop disease progression or are unable to tolerate the study drug
  • Experimental: Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
86
October 2006
April 2006   (final data collection date for primary outcome measure)

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:

    • 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
Both
18 Years and older
No
 
 
 
 
NCT00091806
Global Development Leader, Amgen Inc.
 
Amgen
 
Study Director: MD Amgen
Amgen
July 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.