Trial · NCT02657551
A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer
NCT02657551, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2023-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer. Trials, record NCT02657551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02657551
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer
- NCT number
- NCT02657551
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Thyroid Cancer
- Interventions
- Regorafenib
- First posted
- 2016-01-18
- Last updated
- 2026-08-12
- Results first posted
- 2023-11-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 10-month Progression-free Survival (PFS) Rate [MTC Cohort] | 10 months | 10-month PFS Rate is the proportion of participants ramaing alive and progression free at 10 months. Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
| Primary | Objective Response Rate (ORR) [DTC Cohort] | Up to 23.9 months. Tumor assessments were performed at baseline, on Day 1 of Cycle 3, and every 28 days thereafter. After treatment discontinuation, assessments continued every 2 months (±7 days). | ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Grade 3-5 Toxicity Rate | AEs were evaluated on treatment cycle 1 day 1 of week 1, 2 and 3, and cycle 2 day 1 of week 1 and 3, and cycle 3 and beyond day 1 of week 1. For this study cohort, participants were evaluated for AEs for the maximum treatment duration up to 24 months. | Grade 3-5 toxicity rate is defined as the proportion of participants who experienced at least one grade 3-5 adverse event (AE) of any type during the time of observation. All AEs were summarized and graded based on CTCAE v4. |
| Secondary | Change From Cycle 1 Day 1 in MD Anderson Symptom Inventory-Thyroid (MDASI-Thy) Score | Assessed at Cycle 1 Day 1 and end of treatment. The maximum treatment duration was 23.9 months. | The MDASI-Thy assesses the severity of symptoms, including 13 core symptom items, 6 additional module symptom items, and 6 interference items, at their worst in the past 24 hours using a 0-10 numerical rating scale, where higher scores indicate worse symptoms. For each section (core symptoms, thyroid-specific symptoms, and interference), the section score is calculated as the mean of the item scores and therefore ranges from 0 to 10. Change scores were calculated as the end-of-treatment section score minus the corresponding Cycle 1 Day 1 section score. |
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 | 10-month Progression-free Survival (PFS) Rate [MTC Cohort] | Disease was evaluated through imaging scan on baseline, Cycle 1 Day 1, end of treatment and during follow-up. Relevant to this endpoint is 10 Months | proportion of participants | NUMBER | |
| PRIMARY | Response Rate [Differentiated Thyroid Cancer (DTC)] DATA NOT MATURE YET | 2 Years | |||
| SECONDARY | Grade 3-5 Treatment-related Toxicity Rate [MTC Cohort] | AEs were evaluated on treatment cycle 1 day 1 of week 1, 2 and 3, and cycle 2 day 1 of week 1 and 3, and cycle 3 and beyond day 1 of week 1. For this study cohort, participants were evaluated for AEs for the maximum treatment duration up to 24 months. | proportion of participant | NUMBER | |
| SECONDARY | Quality of Life (QOL) DATA NOT MATURE YET | Reported cycle 1 and 2 on day 1 of week 1 and 3, cycle 3 and beyond on day 1 of week 1, EOT, and follow-up. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 10-month Progression-free Survival (PFS) Rate [MTC Cohort] | MTC Cohort | 0.125 | 95% Confidence Interval 0.003 to 0.527 | proportion of participants | |
| Grade 3-5 Treatment-related Toxicity Rate [MTC Cohort] | MTC Cohort | 0.625 | 95% Confidence Interval 0.24 to 0.91 | proportion of participant |
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 Metastatic Medullary Thyroid Carcinoma (MTC) | 8 | |
| Overall Study | COMPLETED | Regorafenib Metastatic Medullary Thyroid Carcinoma (MTC) | 0 | |
| Overall Study | NOT COMPLETED | Regorafenib Metastatic Medullary Thyroid Carcinoma (MTC) | 8 |
Source ClinicalTrials.gov
Adverse events87
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 | Anemia | Blood and lymphatic system disorders | MTC Cohort | 2 | 8 | |
| other | Sinus tachycardia | Cardiac disorders | MTC Cohort | 1 | 8 | |
| other | Ear pain | Ear and labyrinth disorders | MTC Cohort | 1 | 8 | |
| other | Dry eye | Eye disorders | MTC Cohort | 2 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | MTC Cohort | 3 | 8 | |
| other | Colitis | Gastrointestinal disorders | MTC Cohort | 1 | 8 | |
| other | Constipation | Gastrointestinal disorders | MTC Cohort | 2 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | MTC Cohort | 8 | 8 | |
| other | Dry mouth | Gastrointestinal disorders | MTC Cohort | 2 | 8 | |
| other | Dysphagia | Gastrointestinal disorders | MTC Cohort | 1 | 8 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MTC Cohort | 4 | 8 |
| Total, other adverse events | MTC Cohort | 8 | 8 |
| Total, serious adverse events | MTC Cohort | 5 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30069758 | 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/NCT02657551
GET https://conductscience.org/api/trials/v1/NCT02657551/events?page=2