Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

NCT00091806 | Completed Phase 1

• 1 other identifier: 20030251
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tumors; Oncology; Solid Tumors

Keywords

Targeted Therapy; Solid tumors; ABX-EGF, panitumumab; EGFr; Immunex, Abgenix, Amgen; Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

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)

Cohort 2

EXPERIMENTAL

Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.

Drug: Panitumumab

Interventions

panitumumab (ABX-EGF) DRUG

6 mg/kg once every 2 weeks

Cohort 1

Panitumumab DRUG

9 mg/kg once every 3 weeks

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

Sponsors & Collaborators

• Amgen: lead

Related 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 tumors. Clin Colorectal Cancer. 2009 Jan;8(1):29-37. doi: 10.3816/CCC.2009.n.005.

  PMID: 19203894 RESULT

Related 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

MeSH Terms

Conditions

Neoplasms

Interventions

Panitumumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2004
• First Posted: September 21, 2004
• Study Start: August 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 10, 2009

Record last verified: 2009-07