Trial · NCT01298570
Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
NCT01298570, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2018-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer. Trials, record NCT01298570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01298570
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
- NCT number
- NCT01298570
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- Regorafenib (BAY 73-4506), FOLFIRI, Placebo, FOLFIRI
- First posted
- 2011-02-17
- Last updated
- 2021-01-06
- Results first posted
- 2018-02-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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 diameter of target lesions; 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 appearance of new lesions. |
| Secondary | Overall Response(OR)Rate | 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. |
| Secondary | Disease Control (DC) Rate | 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 appearance of new lesions. |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Drug Metabolism | 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. |
| Secondary | Percentage of Patients With Severe Adverse Events | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | 5.5 years | Months | MEDIAN | |
| SECONDARY | Overall Response(OR)Rate | 3 years | Only evaluable participants (those who had RECIST measurements after baseline) were included in this analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control (DC) Rate | 3 years | Only evaluable participants (those who had RECIST measurements after baseline) were included in this analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | 5.5 years | Months | MEDIAN | |
| SECONDARY | Drug Metabolism | 28 days | This objective was designed to only look at a small subset of participants (11 on each arm) | AUC/dose=(ng/mL*h)/(mg/m^2) | MEDIAN |
| SECONDARY | Percentage of Patients With Severe Adverse Events | 3 years | All patients who received treatment | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm A | 6.1 | 95% Confidence Interval 5.5 to 7.3 | Months | |
| Progression Free Survival (PFS) | Arm B | 5.3 | 95% Confidence Interval 4.1 to 6.0 | Months | |
| Overall Response(OR)Rate | Arm A | Complete Response (CR) | 0 | Participants | |
| Overall Response(OR)Rate | Arm B | Complete Response (CR) | 0 | Participants | |
| Overall Response(OR)Rate | Arm A | Partial Response (PR) | 35 | Participants | |
| Overall Response(OR)Rate | Arm B | Partial Response (PR) | 12 | Participants | |
| Overall Response(OR)Rate | Arm A | Other | 67 | Participants | |
| Overall Response(OR)Rate | Arm B | Other | 46 | Participants | |
| Disease Control (DC) Rate | Arm A | Disease Control Total (CR+PR+SD) | 84 | Participants | |
| Disease Control (DC) Rate | Arm B | Disease Control Total (CR+PR+SD) | 43 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 120 | |
| Overall Study | STARTED | Arm B | 61 | |
| Overall Study | COMPLETED | Arm A | 0 | |
| Overall Study | COMPLETED | Arm B | 0 | |
| Overall Study | NOT COMPLETED | Arm A | 120 | |
| Overall Study | NOT COMPLETED | Arm B | 61 |
Source ClinicalTrials.gov
Adverse events324
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Arm A | 41 | 120 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B | 9 | 61 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Arm A | 7 | 120 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Arm B | 3 | 61 | |
| other | Alanine aminotransferase increased | Investigations | Arm A | 30 | 120 | |
| other | Alanine aminotransferase increased | Investigations | Arm B | 9 | 61 | |
| other | Alkaline phosphatase increased | Investigations | Arm A | 35 | 120 | |
| other | Alkaline phosphatase increased | Investigations | Arm B | 14 | 61 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm A | 30 | 120 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm B | 15 | 61 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 112 | 120 |
| Total, all-cause mortality | Arm B | 59 | 61 |
| Total, other adverse events | Arm A | 118 | 120 |
| Total, other adverse events | Arm B | 61 | 61 |
| Total, serious adverse events | Arm A | 60 | 120 |
| Total, serious adverse events | Arm B | 20 | 61 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A vs Arm B: deaths from any cause | Trial comparisons |
| Arm A vs Arm B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01298570
GET https://conductscience.org/api/trials/v1/NCT01298570/results?page=2