Trial · NCT03207347
A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)
NCT03207347, Phase 2, Completed, University of Florida; results first posted 2023-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001). Trials, record NCT03207347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03207347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)
- NCT number
- NCT03207347
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Mesothelioma, Uveal Melanoma, Renal Cell Carcinoma, Cholangiocarcinoma
- Interventions
- Niraparib
- First posted
- 2017-07-02
- Last updated
- 2023-09-15
- Results first posted
- 2023-09-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 1 year | 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). |
| Secondary | Progression-Free Survival | 8 months | 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. |
| Secondary | Progression-Free Survival Rate at 3 Months | 3 months | 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. |
| Secondary | Progression-Free Survival Rate at 6 Months | 6 months | 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. |
| Secondary | Overall Survival | 10 months | 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 ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | 1 year | 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. | percentage of subjects | NUMBER |
| SECONDARY | Progression-Free Survival | 8 months | months | MEDIAN | |
| SECONDARY | Progression-Free Survival Rate at 3 Months | 3 months | percentage of subjects | NUMBER | |
| SECONDARY | Progression-Free Survival Rate at 6 Months | 6 months | percentage of subjects | NUMBER | |
| SECONDARY | Overall Survival | 10 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Cohort A | 5.6 | 95% Confidence Interval 0.1 to 27.3 | percentage of subjects | |
| Objective Response Rate (ORR) | Cohort B | 0 | 95% Confidence Interval 0 to 0 | percentage of subjects | |
| Progression-Free Survival | Cohort A | 2.1 | 95% Confidence Interval 1.8 to 9.1 | months | |
| Progression-Free Survival | Cohort B | 7.2 | 95% Confidence Interval 1.8 to 12.5 | months | |
| Progression-Free Survival Rate at 3 Months | Cohort A | 43 | 95% Confidence Interval 23 to 62 | percentage of subjects | |
| Progression-Free Survival Rate at 3 Months | Cohort B | 64 | 95% Confidence Interval 34 to 83 | percentage of subjects | |
| Progression-Free Survival Rate at 6 Months | Cohort A | 39 | 95% Confidence Interval 20 to 58 | percentage of subjects | |
| Progression-Free Survival Rate at 6 Months | Cohort B | 57 | 95% Confidence Interval 28 to 78 | percentage of subjects | |
| Overall Survival | Cohort A | 9.1 | 95% Confidence Interval 2.0 to 13.0 | months | |
| Overall Survival | Cohort B | 7.2 | 95% Confidence Interval 2.9 to 15.5 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 23 | |
| Overall Study | STARTED | Cohort B (Closed to Enrollment) | 14 | |
| Overall Study | COMPLETED | Cohort A | 23 | |
| Overall Study | COMPLETED | Cohort B (Closed to Enrollment) | 14 | |
| Overall Study | NOT COMPLETED | Cohort A | 0 | |
| Overall Study | NOT COMPLETED | Cohort B (Closed to Enrollment) | 0 |
Source ClinicalTrials.gov
Adverse events218
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Cohort A | 0 | 23 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort B | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A | 5 | 23 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B | 5 | 14 | |
| other | Alanine aminotransferase increased | Investigations | Cohort A | 2 | 23 | |
| other | Alanine aminotransferase increased | Investigations | Cohort B | 0 | 14 | |
| other | Alkaline phosphatase increased | Investigations | Cohort A | 7 | 23 | |
| other | Alkaline phosphatase increased | Investigations | Cohort B | 0 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A | 7 | 23 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort B | 2 | 14 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 23 | 23 |
| Total, all-cause mortality | Cohort B | 14 | 14 |
| Total, other adverse events | Cohort A | 23 | 23 |
| Total, other adverse events | Cohort B | 14 | 14 |
| Total, serious adverse events | Cohort A | 8 | 23 |
| Total, serious adverse events | Cohort B | 7 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39626160 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A vs Cohort B: deaths from any cause | Trial comparisons |
| Cohort A vs Cohort B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03207347
GET https://conductscience.org/api/trials/v1/NCT03207347/events?page=2