Study Complete
Sponsor ID
20050203

PRIME: Panitumumab Randomized Trial In Combination with Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

Sponsor ID
20050203
Clinicaltrials.gov ID
NCT00364013
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer

Additional Study Details

Phase
Phase 3
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
1183
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-free survival

Timeframe: From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.

Secondary Outcome Measures

Overall survival

Timeframe: From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 144 weeks.

Percentage of participants with an objective response

Timeframe: Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.

Time to progression

Timeframe: From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks

Duration of response

Timeframe: Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.

Number of participants with adverse events

Timeframe: From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 144 weeks.

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.