CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 377 enrolled
Drug / intervention
Panitumumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01412957
NCT01412957Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer

Amgen·interventional·Posted Aug 9, 2011·Updated Mar 15, 2017

In Brief

A Phase 3 clinical trial evaluating Best Supportive Care (BSC) and Panitumumab for Metastatic Colorectal Cancer. Completed, enrolled 377 participants across 78 sites in 16 countries.

Detailed Summary

The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesBrazil, Canada, Chile, China, Croatia, Estonia, Greece, India, Latvia, Lithuania, Malaysia, Mexico, Philippines, Romania, Serbia, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2014
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.9 years ago

Interventions

Best Supportive Care (BSC)other

BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated.

Panitumumabdrug

Administered intravenously