Trial · NCT02053376
A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy
NCT02053376, Phase 2, Completed, Nathan Bahary, MD; results first posted 2019-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy. Trials, record NCT02053376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02053376
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy
- NCT number
- NCT02053376
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Nathan Bahary, MD
- Conditions
- Metastatic Biliary Tract Carcinoma
- Interventions
- Regorafenib
- First posted
- 2014-02-03
- Last updated
- 2019-01-30
- Results first posted
- 2019-01-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 4 years | Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Primary | Progression-free Survival (PFS) - Two or More Doses | up to 4 years | Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Proportion of Participants With Overall Response (OR) | Up to 4 years | The number of patients who experienced a Partial Response (PR) + the number of patients who experienced a Complete Response (CR) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Overall Survival (OS) | Up to 4 years | The length of time from the start of study treatment that patients remained alive. |
| Secondary | Overall Survival (OS) - Two or More Doses | Up to 4 years | The length of time from the start of study treatment that patients remained alive. |
| Secondary | Disease Control Rate (DCR) | Up to 4 years | Number of patients who achieved Complete Response (CR) + number of patients who achieved Partial Response (PR) + number of patients who achieved Stable Disease (SD) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study treatment. |
| Secondary | Changes in Cancer Antigen 19-9 (CA19-9) Level | At baseline prior to treatment and after all treatment received, up to 4 years | The difference between the levels of Cancer antigen 19-9 (CA19-9) prior to treatment compared to after treatment. |
| Secondary | Change in Carcinoembryonic Antigen (CEA) | At baseline prior to treatment and after all treatment received, up to 4 years. | The difference between the levels of Carcinoembryonic antigen (CEA) prior to treatment compared to after treatment. ng/ml |
Source ClinicalTrials.gov
Outcomes8
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) | Up to 4 years | Patients who received at least one dose of regorafenib. | months | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) - Two or More Doses | up to 4 years | Patients who received two or more doses of regorafenib. | months | MEDIAN |
| SECONDARY | Proportion of Participants With Overall Response (OR) | Up to 4 years | Patients who received at least one dose of regorafenib and were evaluable for response | proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 4 years | Patients who received at least one dose of regorafenib. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Two or More Doses | Up to 4 years | Patients who received two or more doses of regorafenib. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to 4 years | Patients who received at least one dose of regorafenib and were evaluable for response | proportion of participants | NUMBER |
| SECONDARY | Changes in Cancer Antigen 19-9 (CA19-9) Level | At baseline prior to treatment and after all treatment received, up to 4 years | Patients who received at least one dose of regorafenib and for which CA19-9 levels were obtainable. | mg/dL | MEDIAN |
| SECONDARY | Change in Carcinoembryonic Antigen (CEA) | At baseline prior to treatment and after all treatment received, up to 4 years. | Patients who received at least one dose of regorafenib. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group9
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) | Regorafenib | 3.58 | 90% Confidence Interval 2.96 to 5.68 | months | |
| Progression-free Survival (PFS) - Two or More Doses | Regorafenib | 3.91 | 90% Confidence Interval 3.55 to 7.39 | months | |
| Proportion of Participants With Overall Response (OR) | Regorafenib | 0.147 | 90% Confidence Interval 0.060 to 0.285 | proportion of participants | |
| Overall Survival (OS) | Regorafenib | 5.55 | 90% Confidence Interval 4.43 to 13.4 | months | |
| Overall Survival (OS) - Two or More Doses | Regorafenib | 9.43 | 90% Confidence Interval 5.72 to 19.4 | months | |
| Disease Control Rate (DCR) | Regorafenib | 0.706 | 90% Confidence Interval 0.552 to 0.831 | proportion of participants | |
| Changes in Cancer Antigen 19-9 (CA19-9) Level | Regorafenib | Before Treatment | 100.6 | Full Range 6.9 to 20558.0 | mg/dL |
| Changes in Cancer Antigen 19-9 (CA19-9) Level | Regorafenib | After Treatment | 186.6 | Full Range 8.0 to 28842.0 | mg/dL |
| Change in Carcinoembryonic Antigen (CEA) | Regorafenib | 3.88 | 90% Confidence Interval 1.11 to 6.90 | ng/ml |
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 | 43 | |
| Overall Study | COMPLETED | Regorafenib | 43 | |
| Overall Study | NOT COMPLETED | Regorafenib | 0 |
Source ClinicalTrials.gov
Adverse events111
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 | Regorafenib | 33 | 43 | |
| other | Sinus bradycardia | Cardiac disorders | Regorafenib | 4 | 43 | |
| other | Sinus tachycardia | Cardiac disorders | Regorafenib | 12 | 43 | |
| other | Flatulence | Gastrointestinal disorders | Regorafenib | 4 | 43 | |
| other | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Regorafenib | 5 | 43 | |
| other | Ascites | Gastrointestinal disorders | Regorafenib | 6 | 43 | |
| other | Constipation | Gastrointestinal disorders | Regorafenib | 7 | 43 | |
| other | Vomiting | Gastrointestinal disorders | Regorafenib | 11 | 43 | |
| other | Diarrhea | Gastrointestinal disorders | Regorafenib | 13 | 43 | |
| other | Nausea | Gastrointestinal disorders | Regorafenib | 13 | 43 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib | 39 | 43 |
| Total, other adverse events | Regorafenib | 43 | 43 |
| Total, serious adverse events | Regorafenib | 27 | 43 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02053376
GET https://conductscience.org/api/trials/v1/NCT02053376/events?page=2