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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors; Oncology; Tumors
• Intervention / Treatment: Drug: panitumumab (ABX-EGF); Drug: Panitumumab

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors.	2 years

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General 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.

Helpful Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: September 17, 2004
• First Submitted That Met QC Criteria: September 20, 2004
• First Posted (Estimate): September 21, 2004

Study Record Updates

• Last Update Posted (Estimate): July 10, 2009
• Last Update Submitted That Met QC Criteria: July 9, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Solid tumors; Monoclonal Antibody; Targeted Therapy; ABX-EGF, panitumumab; EGFr; Immunex, Abgenix, Amgen
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: 20030251