Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00091806
First received: September 17, 2004
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Tumors
Oncology
Solid Tumors
Drug: panitumumab (ABX-EGF)
Drug: Panitumumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 86
Study Start Date: August 2004
Study Completion Date: October 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091806

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

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00091806     History of Changes
Other Study ID Numbers: 20030251
Study First Received: September 17, 2004
Last Updated: July 9, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Western Institutional Review Board

Keywords provided by Amgen:
Targeted Therapy
Solid tumors
ABX-EGF, panitumumab
EGFr
Immunex, Abgenix, Amgen
Monoclonal Antibody

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014