Trials / Completed
CompletedNCT00411450
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.
Conditions
- Colon Cancer
- Colorectal Cancer
- Rectal Cancer
- Cancer
- Metastatic Cancer
- Metastatic Colorectal Cancer
- Oncology
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Panitumumab | Administered by intravenous infusion |
| DRUG | FOLFIRI | Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines. |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2009-01-01
- Completion
- 2010-10-01
- First posted
- 2006-12-14
- Last updated
- 2016-02-15
- Results posted
- 2016-02-15
Source: ClinicalTrials.gov record NCT00411450. Inclusion in this directory is not an endorsement.