NCT03397394 · STUDY IN CONTEXT

Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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

ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Intent-to-treat Population (ITT) with measurable disease at Baseline - The ITT population includes all patients who received at least 1 dose of rucaparib. One patient each in the HRD negative and HRD positive groups did not have measurable disease at Baseline.

→

secondary · POSTED

PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.

Intent-to-Treat population - all patients who received at least 1 dose of rucaparib

→

secondary · POSTED

Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).

Intent-to-Treat population - all patients who received at least 1 dose of rucaparib

→

secondary · POSTED

Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.

Safety population - all patients who received at least 1 dose of rucaparib and who had at least 1 PK sample collected. The number analyzed at each timepoint includes only those participants who remained on study and with viable samples collected at that timepoint.

→

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-carcinoma
nct id: NCT03397394
trial label: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
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: 4
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0000
source section id
NCT03397394-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR) Per RECIST Version 1.1
endpoint definition
ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
time origin
Time from first dose to date of progression, up to approximately 19 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-treat Population (ITT) with measurable disease at Baseline - The ITT population includes all patients who received at least 1 dose of rucaparib. One patient each in the HRD negative and HRD positive groups did not have measurable disease 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-carcinoma
nct id
NCT03397394
outcome key
om-0001
source section id
NCT03397394-om-0001
source outcome index
1
endpoint
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
endpoint definition
PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
time origin
Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat population - all patients who received at least 1 dose of rucaparib
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-carcinoma
nct id
NCT03397394
outcome key
om-0002
source section id
NCT03397394-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
time origin
The total study time for reporting of deaths was approximately 19 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat population - all patients who received at least 1 dose of rucaparib
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-carcinoma
nct id
NCT03397394
outcome key
om-0003
source section id
NCT03397394-om-0003
source outcome index
3
endpoint
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
endpoint definition
Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
time origin
From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety population - all patients who received at least 1 dose of rucaparib and who had at least 1 PK sample collected. The number analyzed at each timepoint includes only those participants who remained on study and with viable samples collected at that timepoint.
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-carcinoma
nct id
NCT03397394
outcome key
om-0000
arm key
OG000
arm label
HRD Unknown
regimen
Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0000
arm key
OG001
arm label
HRD Negative
regimen
Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0000
arm key
OG002
arm label
HRD Positive
regimen
Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0000
arm key
OG003
arm label
Overall
regimen
All patients
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0001
arm key
OG000
arm label
HRD Unknown
regimen
Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0001
arm key
OG001
arm label
HRD Negative
regimen
Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0001
arm key
OG002
arm label
HRD Positive
regimen
Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0001
arm key
OG003
arm label
Overall
regimen
All patients
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0002
arm key
OG000
arm label
HRD Unknown
regimen
Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0002
arm key
OG001
arm label
HRD Negative
regimen
Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0002
arm key
OG002
arm label
HRD Positive
regimen
Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
outcome key
om-0002
arm key
OG003
arm label
Overall
regimen
All patients
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03397394-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-ureter-carcinoma
nct id
NCT03397394
harm key
EG000
source section id
NCT03397394-ae
event group key
EG000
event group label
HRD Unknown
serious affected
20
serious at risk
47
other affected
45
other at risk
47
frequency threshold
5
collection period
Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
event definition
Source null
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-carcinoma
nct id
NCT03397394
harm key
EG001
source section id
NCT03397394-ae
event group key
EG001
event group label
HRD Negative
serious affected
14
serious at risk
30
other affected
29
other at risk
30
frequency threshold
5
collection period
Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
event definition
Source null
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-carcinoma
nct id
NCT03397394
harm key
EG002
source section id
NCT03397394-ae
event group key
EG002
event group label
HRD Positive
serious affected
11
serious at risk
20
other affected
19
other at risk
20
frequency threshold
5
collection period
Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
event definition
Source null
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-carcinoma
nct id
NCT03397394
harm key
EG003
source section id
NCT03397394-ae
event group key
EG003
event group label
Overall
serious affected
45
serious at risk
97
other affected
93
other at risk
97
frequency threshold
5
collection period
Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
event definition
Source null
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