NCT03207347 · STUDY IN CONTEXT

A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

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. 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

Determine the objective response rate (ORR), which is defined as the percentage of subjects achieving a best overall response of partial or complete response (according to RECIST v1.1 criteria) from the start of the treatment until disease progression/recurrence or 30 days after the end of treatment, whichever occurs first. Per RECIST v1.1 criteria, a partial response is defined as a 30% or more decrease in the sum of the largest diameters of the target lesions. Per RECIST v1.1 criteria, a complete response is defined as the disappearance of target lesions (lymph nodes identified as lesions must have reduction in short axis to \<10 mm).

The analysis population for both cohorts only includes those subjects with at least one RECIST response assessment at the end of treatment. 6 subjects (5 subjects in Cohort A and 1 subject in Cohort B) did not have at lease one RECIST response assessment at the end of treatment and are not included in the analysis population.

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secondary · POSTED

Determine the median progression-free survival. Progression-free survival is defined as the duration of time from study entry to time of progression or death or the date of last contact, whichever occurs first. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.

Source null

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secondary · POSTED

Determine the progression-free survival rate at 3 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 3 months after study entry. Disease progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.

Source null

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secondary · POSTED

Determine the progression-free survival rate at 6 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 6 months after study entry. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.

Source null

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secondary · POSTED

Estimate the median overall survival. Overall survival is defined as the duration of time from date of study entry until date of death or date of last contact.

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-intraocular-uveal-melanoma
nct id: NCT03207347
trial label: A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)
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.
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: 5
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0000
source section id
NCT03207347-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR)
endpoint definition
Determine the objective response rate (ORR), which is defined as the percentage of subjects achieving a best overall response of partial or complete response (according to RECIST v1.1 criteria) from the start of the treatment until disease progression/recurrence or 30 days after the end of treatment, whichever occurs first. Per RECIST v1.1 criteria, a partial response is defined as a 30% or more decrease in the sum of the largest diameters of the target lesions. Per RECIST v1.1 criteria, a complete response is defined as the disappearance of target lesions (lymph nodes identified as lesions must have reduction in short axis to \<10 mm).
time origin
1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population for both cohorts only includes those subjects with at least one RECIST response assessment at the end of treatment. 6 subjects (5 subjects in Cohort A and 1 subject in Cohort B) did not have at lease one RECIST response assessment at the end of treatment and are not included in the analysis population.
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-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0001
source section id
NCT03207347-om-0001
source outcome index
1
endpoint
Progression-Free Survival
endpoint definition
Determine the median progression-free survival. Progression-free survival is defined as the duration of time from study entry to time of progression or death or the date of last contact, whichever occurs first. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.
time origin
8 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-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0002
source section id
NCT03207347-om-0002
source outcome index
2
endpoint
Progression-Free Survival Rate at 3 Months
endpoint definition
Determine the progression-free survival rate at 3 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 3 months after study entry. Disease progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.
time origin
3 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-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0003
source section id
NCT03207347-om-0003
source outcome index
3
endpoint
Progression-Free Survival Rate at 6 Months
endpoint definition
Determine the progression-free survival rate at 6 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 6 months after study entry. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.
time origin
6 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-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0004
source section id
NCT03207347-om-0004
source outcome index
4
endpoint
Overall Survival
endpoint definition
Estimate the median overall survival. Overall survival is defined as the duration of time from date of study entry until date of death or date of last contact.
time origin
10 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-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0000
arm key
OG000
arm label
Cohort A
regimen
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0000
arm key
OG001
arm label
Cohort B
regimen
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0001
arm key
OG000
arm label
Cohort A
regimen
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0001
arm key
OG001
arm label
Cohort B
regimen
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0002
arm key
OG000
arm label
Cohort A
regimen
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0002
arm key
OG001
arm label
Cohort B
regimen
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0003
arm key
OG000
arm label
Cohort A
regimen
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0003
arm key
OG001
arm label
Cohort B
regimen
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0004
arm key
OG000
arm label
Cohort A
regimen
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
outcome key
om-0004
arm key
OG001
arm label
Cohort B
regimen
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03207347-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-intraocular-uveal-melanoma
nct id
NCT03207347
harm key
EG000
source section id
NCT03207347-ae
event group key
EG000
event group label
Cohort A
serious affected
8
serious at risk
23
other affected
23
other at risk
23
frequency threshold
0
collection period
Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days.
event definition
All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
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-intraocular-uveal-melanoma
nct id
NCT03207347
harm key
EG001
source section id
NCT03207347-ae
event group key
EG001
event group label
Cohort B
serious affected
7
serious at risk
14
other affected
14
other at risk
14
frequency threshold
0
collection period
Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days.
event definition
All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
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