Trial · NCT01828034
First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma
NCT01828034, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2020-11-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma. Trials, record NCT01828034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01828034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma
- NCT number
- NCT01828034
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Advanced Biliary Tract Carcinoma
- Interventions
- Gemcitabine, Cisplatin, MEK162
- First posted
- 2013-04-10
- Last updated
- 2020-11-17
- Results first posted
- 2020-11-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of MEK162 - Phase I | 1 year | In the phase I portion, up to 18 patients will be enrolled in classic 3+3 cohort dose escalation design to identify the MTD of MEK162 when administered with gemcitabine and cisplatin given weeks 2 and 3 of a 3 week cycle . |
| Primary | Six-month Progression Free Survival | 6 months | An exact binomial single stage design will be used to discriminate between true 6-month PFS rates of 59% vs. 82%, and between true response rates of 26% and 50%. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Primary | Objective Response Rate (ORR) | 1 year | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Median PFS | 1 year | progression free survival will be calculated from study entry to documented disease progression or death from any cause, whatever occurs first. |
| Secondary | Median Overall Survival | 1 year | (survival) will be calculated from study entry to death or last follow up |
| Secondary | Participants Evaluated for Toxicity | 2 years | All toxicities will be rated as per the NCI Common Toxicity Criteria, version 4. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MTD of MEK162 - Phase I | 1 year | mg | NUMBER | |
| PRIMARY | Six-month Progression Free Survival | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Objective Response Rate (ORR) | 1 year | 1 participant withdrew consent before starting treatment | percentage of participants with ORR | NUMBER |
| SECONDARY | Median PFS | 1 year | 1 participants withdrew consent before received treatment | months | MEDIAN |
| SECONDARY | Median Overall Survival | 1 year | 1 participant withdrew consent before starting treatment | months | MEAN |
| SECONDARY | Participants Evaluated for Toxicity | 2 years | 1 participants withdrew consent before receiving treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MTD of MEK162 - Phase I | Gemcitabine, Cisplatin and MEK162 | 45 | mg | ||
| Six-month Progression Free Survival | Gemcitabine, Cisplatin and MEK162 | Progression free | 19 | Participants | |
| Six-month Progression Free Survival | Gemcitabine, Cisplatin and MEK162 | Progressed | 23 | Participants | |
| Objective Response Rate (ORR) | Gemcitabine, Cisplatin and MEK162 | 12 | percentage of participants with ORR | ||
| Median PFS | Gemcitabine, Cisplatin and MEK162 | 6 | 95% Confidence Interval 4 to 12 | months | |
| Median Overall Survival | Gemcitabine, Cisplatin and MEK162 | 13.3 | 95% Confidence Interval 9.8 to 16.5 | months | |
| Participants Evaluated for Toxicity | Gemcitabine, Cisplatin and MEK162 | Evaluated for toxicity | 41 | Participants | |
| Participants Evaluated for Toxicity | Gemcitabine, Cisplatin and MEK162 | Not evaluable/withdrew consent before treatment | 1 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 3 | |
| Overall Study | STARTED | Cohort 2 | 6 | |
| Overall Study | STARTED | Cohort 3 | 3 | |
| Overall Study | STARTED | Cohort 4 | 30 | |
| Overall Study | COMPLETED | Cohort 1 | 3 | |
| Overall Study | COMPLETED | Cohort 2 | 6 | |
| Overall Study | COMPLETED | Cohort 3 | 3 | |
| Overall Study | COMPLETED | Cohort 4 | 29 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
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 |
|---|---|---|---|---|---|---|
| serious | Anemia | Blood and lymphatic system disorders | Cohort 1 | 0 | 3 | |
| serious | Anemia | Blood and lymphatic system disorders | Cohort 2 | 0 | 6 | |
| serious | Anemia | Blood and lymphatic system disorders | Cohort 3 | 2 | 3 | |
| serious | Anemia | Blood and lymphatic system disorders | Cohort 4 | 16 | 29 | |
| serious | Blood bilirubin increased | Investigations | Cohort 1 | 0 | 3 | |
| serious | Blood bilirubin increased | Investigations | Cohort 2 | 0 | 6 | |
| serious | Blood bilirubin increased | Investigations | Cohort 3 | 0 | 3 | |
| serious | Blood bilirubin increased | Investigations | Cohort 4 | 7 | 29 | |
| serious | Hyponatremia | Metabolism and nutrition disorders | Cohort 1 | 0 | 3 | |
| serious | Hyponatremia | Metabolism and nutrition disorders | Cohort 2 | 0 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 2 | 3 |
| Total, all-cause mortality | Cohort 2 | 4 | 6 |
| Total, all-cause mortality | Cohort 3 | 1 | 3 |
| Total, all-cause mortality | Cohort 4 | 16 | 29 |
| Total, other adverse events | Cohort 1 | 0 | 0 |
| Total, other adverse events | Cohort 2 | 0 | 0 |
| Total, other adverse events | Cohort 3 | 0 | 0 |
| Total, other adverse events | Cohort 4 | 0 | 0 |
| Total, serious adverse events | Cohort 1 | 1 | 3 |
| Total, serious adverse events | Cohort 2 | 1 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01828034
GET https://conductscience.org/api/trials/v1/NCT01828034/events?page=2