18 and older, any sex, with Colorectal Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· 5.5 years
To compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients failing one prior oxaliplatin-containing regimen for metastatic colorectal cancer. PFS is defined as the time from randomization until metastatic colorectal cancer (mCRC) progression or death as a result of any cause. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diam
Group
Value
95% CI
Arm A
6.1
5.5 – 7.3
Arm B
5.3
4.1 – 6.0
Overall Response(OR)RateSecondary· 3 years
To compare overall response (OR) rates (OR= CR + PR) between ARM A and ARM B as defined via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Group
Value
95% CI
Arm A
0
Arm B
0
Arm A
35
Arm B
12
Arm A
67
Arm B
46
Disease Control (DC) RateSecondary· 3 years
To compare Disease Control (DC) Rate (DC= CR + PR + SD) between ARM A and ARM B as defined via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and Stable Disease (SD) ), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the
Group
Value
95% CI
Arm A
84
Arm B
43
Arm A
18
Arm B
15
Overall Survival (OS)Secondary· 5.5 years
To compare overall survival (OS) between ARM A and ARM B. OS is defined as the time from randomization until death as a result of any cause.
Group
Value
95% CI
Arm A
13.8
10.5 – 14.8
Arm B
11.7
9.0 – 15.9
Drug MetabolismSecondary· 28 days
To compare the pharmacokinetic (PK) profile of FOLFIRI between a subset of patients receiving regorafenib (ARM A) and patients receiving placebo (Arm B). The Area Under the Curve (AUC) levels of the irinotecan metabolite SN-38 were compared.
Cycle 1
Group
Value
95% CI
Arm A
0.68
0.49 – 0.89
Arm B
0.63
0.47 – 0.91
Cycle 2
Group
Value
95% CI
Arm A
0.59
0.24 – 0.85
Arm B
0.72
0.47 – 0.91
Percentage of Patients With Severe Adverse EventsSecondary· 3 years
Toxicity Assessments were made according to NCI CTCAE v. 4.0 . Severe events (grades 3-4) that occurred in a higher percentage of regorafenib treated participants as compared to placebo are reported below.
neutropenia
Group
Value
95% CI
Arm A
41
Arm B
30
diarrhea
Group
Value
95% CI
Arm A
15
Arm B
5
hypophosphatemia
Group
Value
95% CI
Arm A
14
Arm B
0
hypertension
Group
Value
95% CI
Arm A
8
Arm B
2
elevated lipase
Group
Value
95% CI
Arm A
8
Arm B
3
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07514455 — Regorafenib After Treatment Failure of First Line Immune Checkpoint Inhibitor Treatment in Advanced Hepatocellular Carci
· Phase 2
· not yet recruiting
NCT07514429 — Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial
· Phase 2
· not yet recruiting
NCT07328009 — A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma
· Phase 2
· not yet recruiting
NCT06829355 — "Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 6 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01298570.