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Trial record 1 of 1 for:    Panitumumab, 20030251
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Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00091806
Recruitment Status : Completed
First Posted : September 21, 2004
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
Amgen

Tracking Information
First Submitted Date  ICMJE September 17, 2004
First Posted Date  ICMJE September 21, 2004
Last Update Posted Date July 10, 2009
Study Start Date  ICMJE August 2004
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
Official Title  ICMJE An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tumors
  • Oncology
  • Solid Tumors
Intervention  ICMJE
  • Drug: panitumumab (ABX-EGF)
    6 mg/kg once every 2 weeks
  • Drug: Panitumumab
    9 mg/kg once every 3 weeks
Study Arms  ICMJE
  • 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
    Intervention: Drug: panitumumab (ABX-EGF)
  • 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.
    Intervention: Drug: Panitumumab
Publications * Stephenson JJ, Gregory C, Burris H, Larson T, Verma U, Cohn A, Crawford J, Cohen RB, Martin J, Lum P, Yang X, Amado RG. An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. Clin Colorectal Cancer. 2009 Jan;8(1):29-37. doi: 10.3816/CCC.2009.n.005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2007)
86
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00091806
Other Study ID Numbers  ICMJE 20030251
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Global Development Leader, Amgen Inc.
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP