Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091806
• Other study ID #: 20030251
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2004
• Last updated: July 9, 2009
• Start date: August 2004
• Est. completion date: October 2006

Study information

• Verified date: July 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Western Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Oncology
• Solid Tumors
• Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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 tumor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors.		2 years	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling