Trial · NCT02042443
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
NCT02042443, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery. Trials, record NCT02042443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02042443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
- NCT number
- NCT02042443
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma, Hilar Cholangiocarcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma, Recurrent Childhood Liver Cancer, Recurrent Extrahepatic Bile Duct Carcinoma, Recurrent Gallbladder Carcinoma, Stage II Gallbladder Cancer, Stage III Childhood Hepatocellular Carcinoma, Stage IIIA Gallbladder Cancer, Stage IIIB Gallbladder Cancer, Stage IV Childhood Hepatocellular Carcinoma, Stage IV Distal Bile Duct Cancer, Stage IVA Gallbladder Cancer, Stage IVB Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Carcinoma
- Interventions
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Trametinib
- First posted
- 2014-01-22
- Last updated
- 2017-09-12
- Results first posted
- 2017-08-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 2 years from registration | From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 2 years | Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | Objective Response Rate | Up to 2 years from registration | Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR. |
| Secondary | Progression-free Survival | Up to 2 years from registration | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. |
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 | Overall Survival | Up to 2 years from registration | Eligible and analyzable patients. | months | MEDIAN |
| SECONDARY | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 2 years | Eligible patients who received any treatment and were assessed for adverse events are included in this summary. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate | Up to 2 years from registration | All eligible and analyzable patients with measurable disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | Up to 2 years from registration | Eligible and analyzable patients. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Trametinib | 4.3 | 95% Confidence Interval 3.1 to 5.1 | months | |
| Overall Survival | Chemotherapy | 7.9 | 95% Confidence Interval 3.2 to 14.6 | months | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Trametinib | Alanine aminotransferase increased | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chemotherapy | Alanine aminotransferase increased | 0 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Trametinib | Anemia | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chemotherapy | Anemia | 0 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Trametinib | Ascites | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chemotherapy | Ascites | 0 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Trametinib | Aspartate aminotransferase increased | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chemotherapy | Aspartate aminotransferase increased | 0 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trametinib | 27 | |
| Overall Study | STARTED | Chemotherapy | 26 | |
| Overall Study | Eligible and Analyzable | Trametinib | 24 | |
| Overall Study | Eligible and Analyzable | Chemotherapy | 20 | |
| Overall Study | COMPLETED | Trametinib | 0 | |
| Overall Study | COMPLETED | Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Trametinib | 27 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 26 |
Source ClinicalTrials.gov
Adverse events238
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 | Trametinib | 8 | 23 | |
| other | Anemia | Blood and lymphatic system disorders | Chemotherapy | 8 | 20 | |
| other | Ear and labyrinth disorders-Other | Ear and labyrinth disorders | Trametinib | 0 | 23 | |
| other | Ear and labyrinth disorders-Other | Ear and labyrinth disorders | Chemotherapy | 1 | 20 | |
| other | Hearing impaired | Ear and labyrinth disorders | Trametinib | 0 | 23 | |
| other | Hearing impaired | Ear and labyrinth disorders | Chemotherapy | 1 | 20 | |
| other | Dry eye | Eye disorders | Trametinib | 3 | 23 | |
| other | Dry eye | Eye disorders | Chemotherapy | 2 | 20 | |
| other | Watering eyes | Eye disorders | Trametinib | 0 | 23 | |
| other | Watering eyes | Eye disorders | Chemotherapy | 2 | 20 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trametinib | ||
| Total, all-cause mortality | Chemotherapy | ||
| Total, other adverse events | Trametinib | 21 | 23 |
| Total, other adverse events | Chemotherapy | 19 | 20 |
| Total, serious adverse events | Trametinib | 13 | 23 |
| Total, serious adverse events | Chemotherapy | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Trametinib vs Chemotherapy: serious adverse events |
Source 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/NCT02042443
GET https://conductscience.org/api/trials/v1/NCT02042443/results?page=2