Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Oncology; Tumors; Solid Tumors
• Interventions: Drug: panitumumab (ABX-EGF); Drug: Panitumumab

• Registration Number: NCT00091806
• Lead Sponsor: Amgen

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 available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-09-17
• Study First Submitted QC: 2004-09-20
• Study First Posted: 2004-09-21
• Primary Completion: 2006-04
• Study Completion: 2006-10
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	panitumumab (ABX-EGF)	6mg/kg of panitumumab administered once every 2 weeks until subjects develop disease progression or are unable to tolerate the study drug
Cohort 2	Panitumumab	Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.

Primary Outcome Measures

Name	Time	Method
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

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