Phase 3
N=760
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
Metastatic Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01103323 ↗Enrolled (actual)
760
Serious AEs
44.5%
Results posted
Nov 2012
Primary outcome: Primary: Overall Survival — 196; 151 Days — p=0.005178
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Regorafenib (Stivarga, BAY73-4506) (Drug); Placebo (Drug); Best Supportive Care (BSC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
196; 151 | 0.005178 sig |
| SECONDARY Progression-free Survival (Based on Investigator's Assessment) |
59; 52 | <0.000001 sig |
| SECONDARY Objective Tumor Response |
1.0; 0.4 | 0.188432 |
| SECONDARY Disease Control |
41.0; 14.9 | <0.000001 sig |
| SECONDARY Tumor Response |
0; 0; 1.0; 0.4; 42.8; 14.5 | — |
Summary
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC
Eligibility Criteria
Inclusion Criteria
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
- Patients with measurable or non measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of /= grade 3
- Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity </= Grade 2
Data sourced from ClinicalTrials.gov (NCT01103323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.