Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer

NCT ID: NCT00089635

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-01
• Study Completion Date: 2008-08-01

Brief Summary

The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.

Conditions

Colorectal Cancer; Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panitumumab

Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: DRUG

Administered by intravenous infusion

Interventions

Panitumumab

Administered by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

ABX-EGF; Vectibix®

Eligibility Criteria

Inclusion Criteria

• Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
• Metastatic colorectal carcinoma
• Eastern Cooperative Oncology Group of 0, 1 or 2
• Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
• Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
• Bidimensionally measurable disease
• Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by immunohistochemistry
• At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
• Adequate hematologic, renal and hepatic function

Exclusion Criteria

• Symptomatic brain metastases requiring treatment
• Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
• Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
• Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
• Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Liao MZ, Prenen H, Dutta S, Upreti VV. The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer. Cancer Chemother Pharmacol. 2021 Oct;88(4):665-672. doi: 10.1007/s00280-021-04319-w. Epub 2021 Jul 2.

Reference Type: DERIVED

PMID: 34213592 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

http://www.vectibix.com/

FDA-approved Drug Labeling

Other Identifiers

20030250

Identifier Type: -

Identifier Source: org_study_id

NCT00112944

Identifier Type: -

Identifier Source: nct_alias