Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Eligible and analyzable patients.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

All eligible and analyzable patients with measurable disease.

→

secondary · POSTED

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.

Eligible and analyzable patients.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id: NCT02042443
trial label: Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0000
source section id
NCT02042443-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
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.
time origin
Up to 2 years from registration
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and analyzable patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0001
source section id
NCT02042443-om-0001
source outcome index
1
endpoint
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
endpoint definition
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.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0002
source section id
NCT02042443-om-0002
source outcome index
2
endpoint
Objective Response Rate
endpoint definition
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.
time origin
Up to 2 years from registration
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible and analyzable patients with measurable disease.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0003
source section id
NCT02042443-om-0003
source outcome index
3
endpoint
Progression-free Survival
endpoint definition
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.
time origin
Up to 2 years from registration
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and analyzable patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0000
arm key
OG000
arm label
Trametinib
regimen
Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0000
arm key
OG001
arm label
Chemotherapy
regimen
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0001
arm key
OG000
arm label
Trametinib
regimen
Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0001
arm key
OG001
arm label
Chemotherapy
regimen
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0002
arm key
OG000
arm label
Trametinib
regimen
Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0002
arm key
OG001
arm label
Chemotherapy
regimen
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0003
arm key
OG000
arm label
Trametinib
regimen
Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
outcome key
om-0003
arm key
OG001
arm label
Chemotherapy
regimen
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02042443-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
harm key
EG000
source section id
NCT02042443-ae
event group key
EG000
event group label
Trametinib
serious affected
13
serious at risk
23
other affected
21
other at risk
23
frequency threshold
5
collection period
Up to 2 years
event definition
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-recurrent-58014c21
nct id
NCT02042443
harm key
EG001
source section id
NCT02042443-ae
event group key
EG001
event group label
Chemotherapy
serious affected
1
serious at risk
20
other affected
19
other at risk
20
frequency threshold
5
collection period
Up to 2 years
event definition
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice