Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.

Source null

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secondary · POSTED

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Source null

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secondary · POSTED

Estimated using the product-limit method of Kaplan and Meier.

Source null

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secondary · POSTED

Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as "unrelated" or "unlikely related" to study drugs). Toxicities graded using CTCAEv4 criteria.

Source null

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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-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id: NCT02178241
trial label: Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
applicability: unclear
applicability note: Attached because the study's own record describes metastatic 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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0000
source section id
NCT02178241-om-0000
source outcome index
0
endpoint
Observed Overall Response Rate
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.
time origin
Up to 36 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0001
source section id
NCT02178241-om-0001
source outcome index
1
endpoint
Progression-free Survival
endpoint definition
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
time origin
From the start until progression, death, or the start of another treatment, assessed up to 12 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0002
source section id
NCT02178241-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Estimated using the product-limit method of Kaplan and Meier.
time origin
From start of treatment until death from any cause ,up to 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0003
source section id
NCT02178241-om-0003
source outcome index
3
endpoint
Incidence of Adverse Events.
endpoint definition
Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as "unrelated" or "unlikely related" to study drugs). Toxicities graded using CTCAEv4 criteria.
time origin
Up to 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0000
arm key
OG000
arm label
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)
regimen
Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178241-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0001
arm key
OG000
arm label
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)
regimen
Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178241-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0002
arm key
OG000
arm label
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)
regimen
Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178241-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
outcome key
om-0003
arm key
OG000
arm label
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)
regimen
Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178241-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02178241
harm key
EG000
source section id
NCT02178241-ae
event group key
EG000
event group label
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)
serious affected
16
serious at risk
24
other affected
24
other at risk
24
frequency threshold
0
collection period
Adverse events occurred over a period of 2 years and 10 months.
event definition
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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