Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

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

Tracking Information

• First Submitted Date: September 17, 2004
• First Posted Date: September 21, 2004
• Last Update Posted Date: July 10, 2009
• Study Start Date: August 2004
• Actual Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Tumors
• Oncology
• Solid Tumors

Intervention

• Drug: panitumumab (ABX-EGF)
  6 mg/kg once every 2 weeks
• Drug: Panitumumab
  9 mg/kg once every 3 weeks

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 5, 2007): 86
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2006
• Actual Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00091806
• Other Study ID Numbers: 20030251
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Global Development Leader, Amgen Inc.
• Study Sponsor: Amgen
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: July 2009