Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal Cancer

NCT00113776 | Completed Phase 2

• 1 other identifier: 20030194
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.

Conditions

Colorectal Cancer

Keywords

Metastatic Colorectal Cancer, Colon; Colorectal, Rectal Cancer, EGFr; Metastatic, Cancer, ABX-EGF; Panitumumab, Clinical Trial; Immunex, Abgenix, Amgen

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse events

• Changes in Lab values

• Incidence of HAHA formation

Interventions

ABX-EGF DRUG

Eligibility Criteria

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

Sponsors & Collaborators

• Amgen: lead

Related Publications (3)

• Van Cutsem E, Siena S, Humblet Y, Canon JL, Maurel J, Bajetta E, Neyns B, Kotasek D, Santoro A, Scheithauer W, Spadafora S, Amado RG, Hogan N, Peeters M. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol. 2008 Jan;19(1):92-8. doi: 10.1093/annonc/mdm399. Epub 2007 Sep 4.

  PMID: 17785764 RESULT

• Safari M, Esmaeili H, Mahjub H, Roshanaei G. Estimation of treatment effect in presence of noncompliance and competing risks: a simulation study. Sci Rep. 2023 Aug 18;13(1):13477. doi: 10.1038/s41598-023-40538-2.

  PMID: 37596461 DERIVED

• Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3.

  PMID: 18316791 DERIVED

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

Colorectal Neoplasms; Rectal Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2005
• First Posted: June 13, 2005
• Last Updated: January 21, 2011

Record last verified: 2011-01