NCT02612194 · STUDY IN CONTEXT

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is required.

Study was designed to evaluate objective response rate overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment. Analysis of overall response rate was conducted on those patients in the efficacy population with measurable disease present at baseline.

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secondary · POSTED

Overall survival was defined as the duration from enrollment date to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.

Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.

→

secondary · POSTED

PFS was defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled assessments will be censored at date of last assessment prior to first missed assessment.

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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-ureter-neoplasm
nct id: NCT02612194
trial label: LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 3
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ureter-neoplasm
nct id
NCT02612194
outcome key
om-0000
source section id
NCT02612194-om-0000
source outcome index
0
endpoint
Overall Response
endpoint definition
Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is required.
time origin
From enrollment to best response while on crizotinib; Subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for an average of 6 weeks)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Study was designed to evaluate objective response rate overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment. Analysis of overall response rate was conducted on those patients in the efficacy population with measurable disease present at baseline.
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-ureter-neoplasm
nct id
NCT02612194
outcome key
om-0001
source section id
NCT02612194-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Overall survival was defined as the duration from enrollment date to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.
time origin
From date of treatment start to date of death, or censored as described above; assessed for approximately 2 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.
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-ureter-neoplasm
nct id
NCT02612194
outcome key
om-0002
source section id
NCT02612194-om-0002
source outcome index
2
endpoint
Progression Free Survival
endpoint definition
PFS was defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled assessments will be censored at date of last assessment prior to first missed assessment.
time origin
From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 2 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.
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-ureter-neoplasm
nct id
NCT02612194
outcome key
om-0000
arm key
OG000
arm label
Total Enrolled Study Cohort
regimen
This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02612194-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ureter-neoplasm
nct id
NCT02612194
outcome key
om-0001
arm key
OG000
arm label
Total Enrolled Study Cohort
regimen
This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02612194-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ureter-neoplasm
nct id
NCT02612194
outcome key
om-0002
arm key
OG000
arm label
Total Enrolled Study Cohort
regimen
This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02612194-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-ureter-neoplasm
nct id
NCT02612194
harm key
EG000
source section id
NCT02612194-ae
event group key
EG000
event group label
Cohort 1
serious affected
2
serious at risk
6
other affected
5
other at risk
6
frequency threshold
0
collection period
Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal.
event definition
Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
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-ureter-neoplasm
nct id
NCT02612194
harm key
EG001
source section id
NCT02612194-ae
event group key
EG001
event group label
Cohort 2
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal.
event definition
Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
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-ureter-neoplasm
nct id
NCT02612194
harm key
EG002
source section id
NCT02612194-ae
event group key
EG002
event group label
Cohort 3
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal.
event definition
Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
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-ureter-neoplasm
nct id
NCT02612194
harm key
EG003
source section id
NCT02612194-ae
event group key
EG003
event group label
Total
serious affected
4
serious at risk
8
other affected
7
other at risk
8
frequency threshold
0
collection period
Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal.
event definition
Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
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