Trials / Completed
CompletedNCT00113763
Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 463 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Best supportive care | Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases). |
| DRUG | Panitumumab | Intravenous infusion at a dose of 6 mg/kg once every 2 weeks. |
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2008-10-01
- Completion
- 2009-06-01
- First posted
- 2005-06-13
- Last updated
- 2022-11-07
- Results posted
- 2014-01-03
Source: ClinicalTrials.gov record NCT00113763. Inclusion in this directory is not an endorsement.