Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00091806

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tumors Oncology Solid Tumors	Drug: panitumumab (ABX-EGF) Drug: Panitumumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

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

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

Outcome Measures

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. [2 years]

Secondary Outcome Measures

To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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