Trial · NCT02520141
Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
NCT02520141, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery. Trials, record NCT02520141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02520141
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
- NCT number
- NCT02520141
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Cholangiocarcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Stage III Gallbladder Cancer AJCC v7, Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IV Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7, Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7, Stage IVB Gallbladder Cancer AJCC v7, Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7, Unresectable Gallbladder Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Ramucirumab
- First posted
- 2015-08-11
- Last updated
- 2023-06-15
- Results first posted
- 2023-06-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival of Ramucirumab in Advanced Biliary Cancers | Up to 6 years | Progression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment |
| Secondary | Overall Survival (OS) | Up to 6 years | Overal Survival (OS): the time from treatment initiation to death from any cause. OS functions were estimated using the Kaplan-Meier method . |
| Secondary | Overall Response Rate (RR) | Up to 6 years | The proportion of patients with the best overall response of complete response or partial response (PR)\] |
| Secondary | Percentage of Disease Control Rate | Up to 6 years | Partial Response + Complete Response + Stable Disease (ORR + Stable Disease) |
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 | Progression Free Survival of Ramucirumab in Advanced Biliary Cancers | Up to 6 years | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 6 years | Months | MEDIAN | |
| SECONDARY | Overall Response Rate (RR) | Up to 6 years | participants | NUMBER | |
| SECONDARY | Percentage of Disease Control Rate | Up to 6 years | percentage | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival of Ramucirumab in Advanced Biliary Cancers | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 3.2 | 95% Confidence Interval 2.1 to 4.8 | months | |
| Overall Survival (OS) | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 9.5 | 95% Confidence Interval 5.81 to 13.6 | Months | |
| Overall Response Rate (RR) | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV | 1 | participants | ||
| Percentage of Disease Control Rate | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV | 45 | percentage |
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 | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 61 | |
| Overall Study | COMPLETED | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 60 | |
| Overall Study | NOT COMPLETED | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 1 |
Source ClinicalTrials.gov
Adverse events71
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 | Proteinuria | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 23 | 60 | |
| other | Thrombocytopenia | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 13 | 60 | |
| other | Anemia | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 11 | 60 | |
| other | Hyperbilirubinemia | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 9 | 60 | |
| other | Alkaline phosphatase increase | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 9 | 60 | |
| other | AST increase | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 9 | 60 | |
| other | Hyponatremia | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 9 | 60 | |
| other | ALT increase | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 8 | 60 | |
| other | Hyperkalemia | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 7 | 60 | |
| other | Hypercalcemia | Investigations | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 5 | 60 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 60 | 60 |
| Total, other adverse events | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 60 | 60 |
| Total, serious adverse events | Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV. | 1 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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/NCT02520141
GET https://conductscience.org/api/trials/v1/NCT02520141/events?page=2