Trial · NCT02466009
Regorafenib in Metastatic Colorectal Cancer
NCT02466009, Phase 2, Completed, University of Rochester; results first posted 2021-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib in Metastatic Colorectal Cancer. Trials, record NCT02466009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466009
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib in Metastatic Colorectal Cancer
- NCT number
- NCT02466009
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Regorafenib
- First posted
- 2015-06-09
- Last updated
- 2024-09-04
- Results first posted
- 2021-04-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability. | From the date of study entry until 30 days after the last dose of study treatment. | |
| Secondary | Percentage of Subjects Who Responded to Study Treatment | From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years. | Efficacy outcomes will be response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). A participant's best response will be classified per RECIST (Response evaluation criteria in solid tumors) criteria into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). If a participant's best response was complete response, partial response, or stable disease they were classified as responding to treatment. |
| Secondary | Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument | baseline and week 4 | The FACT-C instrument is an 11 question survey that asks general questions about the participants digestive system. The instrument scores range from 0-44 with higher scores indicating digestive problems. |
| Other | Exploratory Outcome Measure: Percentage of Patients Who Had a Correlation Between Adverse Events and Response Rate | week 4 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability. | From the date of study entry until 30 days after the last dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects Who Responded to Study Treatment | From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years. | percentage of participants | NUMBER | |
| SECONDARY | Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument | baseline and week 4 | score on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Exploratory Outcome Measure: Percentage of Patients Who Had a Correlation Between Adverse Events and Response Rate | week 4 |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability. | Regorafenib | 20 | Participants | ||
| Percentage of Subjects Who Responded to Study Treatment | Regorafenib | 3.7 | percentage of participants | ||
| Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument | Regorafenib | -0.82 | Full Range -18.33 to 23.33 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regorafenib | 27 | |
| Overall Study | COMPLETED | Regorafenib | 27 | |
| Overall Study | NOT COMPLETED | Regorafenib | 0 |
Source ClinicalTrials.gov
Adverse events32
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 | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Regorafenib | 4 | 27 | |
| other | Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Regorafenib | 1 | 27 | |
| other | Acute kidney injury | Renal and urinary disorders | Regorafenib | 1 | 27 | |
| other | Confusion | Psychiatric disorders | Regorafenib | 1 | 27 | |
| other | Dizziness | Nervous system disorders | Regorafenib | 1 | 27 | |
| other | Presyncope | Nervous system disorders | Regorafenib | 1 | 27 | |
| other | Syncope | Nervous system disorders | Regorafenib | 1 | 27 | |
| other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Regorafenib | 2 | 27 | |
| other | Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Regorafenib | 1 | 27 | |
| other | Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Regorafenib | 1 | 27 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib | 2 | 27 |
| Total, other adverse events | Regorafenib | 20 | 27 |
| Total, serious adverse events | Regorafenib | 0 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28712102 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02466009
GET https://conductscience.org/api/trials/v1/NCT02466009/events?page=2