Study Complete
Sponsor ID
20060277
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to TreatmentPRECEPT
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.
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.