Study Complete
Sponsor ID
20060277

Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to TreatmentPRECEPT

Sponsor ID
20060277
Clinicaltrials.gov ID
NCT00411450
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
116
Additional Study Details

Protocol Summary

Primary Outcome Measures

Objective response rate at weeks 17 and 25, and best response rate; progressions-free survival at weeks 17 and 25; progression free survival time; disease control; duration of objective response; overall survival

Timeframe: After disease progression, all subjects will be followed every 12 weeks + or - 2 weeks from the safety visit until the end of study (approximately 52 weeks after the last subject is enrolled).

Secondary Outcome Measures

Incidence and severity of AEs, including AEs of interest for panitumumab; changes in selected laboratory values: Mg, potassium, calcium, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, ANC, Hgb and platelet count.

Timeframe: After disease progression, all subjects will be followed every 12 weeks + or - 2 weeks from the safety visit until the end of study (approximately 52 weeks after the last subject is enrolled).

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.