Trial · NCT02872714
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
NCT02872714, Phase 2, Completed, Incyte Corporation; results first posted 2023-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201). Trials, record NCT02872714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02872714
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
- NCT number
- NCT02872714
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 263 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- UC (Urothelial Cancer)
- Interventions
- pemigatinib, pemigatinib
- First posted
- 2016-08-19
- Last updated
- 2025-08-14
- Other registries' IDs
- eudract:2016-001321-14
- Results first posted
- 2023-03-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen | up to 1138 days | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed. |
| Secondary | ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen | up to 817 days | ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed. |
| Secondary | ORR in Participants With All Other FGF/FGFR Alterations | up to 1198 days | ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed. |
| Secondary | ORR in All Participants on an ID or CD Regimen in Combined Cohorts | up to 1198 days | ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 25 weeks | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug. |
| Secondary | Progression-free Survival (PFS) | up to 1138 days | PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee. |
| Secondary | Duration of Response (DOR) | up to 1075 days | DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed |
| Secondary | Overall Survival | up to 1610 days | Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause. |
Source ClinicalTrials.gov
Outcomes8
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) in Participants With FGFR3 Mutations or Fusions on a CD Regimen | up to 1138 days | Efficacy Evaluable Population: all participants enrolled in the study who had a known FGF/FGFR alteration confirmed by the sponsor's central laboratory and who had received at least 1 dose of study drug. The confidence interval was calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen | up to 817 days | Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in Participants With All Other FGF/FGFR Alterations | up to 1198 days | Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in All Participants on an ID or CD Regimen in Combined Cohorts | up to 1198 days | Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 25 weeks | Safety Population: all participants enrolled in the study who had received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | up to 1138 days | Efficacy Evaluable Population. The Other-ID and Other-CD treatment groups were not included in the Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | up to 1075 days | Efficacy Evaluable Population. The Other-ID and Other-CD treatment groups were not included in the Efficacy Evaluable Population. Only participants with a CR or PR were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
| SECONDARY | Overall Survival | up to 1610 days | Efficacy Evaluable Population. The Other-ID and Other-CD treatment groups were not included in the Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group20
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) in Participants With FGFR3 Mutations or Fusions on a CD Regimen | Cohort A-CD: FGFR3 Mutations or Fusions | 17.8 | 95% Confidence Interval 10.92 to 26.70 | percentage of participants | |
| ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen | Cohort A-ID: FGFR3 Mutations or Fusions | 23.3 | 95% Confidence Interval 15.54 to 32.66 | percentage of participants | |
| ORR in Participants With All Other FGF/FGFR Alterations | Cohort B-ID: All Other FGF/FGFR Alterations | 6.8 | 95% Confidence Interval 1.43 to 18.66 | percentage of participants | |
| ORR in All Participants on an ID or CD Regimen in Combined Cohorts | Cohort A-ID + Cohort B-ID | 18.4 | 95% Confidence Interval 12.47 to 25.59 | percentage of participants | |
| ORR in All Participants on an ID or CD Regimen in Combined Cohorts | Cohort A-ID + Cohort A-CD | 20.6 | 95% Confidence Interval 15.26 to 26.79 | percentage of participants | |
| ORR in All Participants on an ID or CD Regimen in Combined Cohorts | Cohort A-ID + Cohort B-ID + Cohort A-CD | 18.1 | 95% Confidence Interval 13.55 to 23.52 | percentage of participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Cohort A-ID: FGFR3 Mutations or Fusions | 103 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Cohort B-ID: All Other FGF/FGFR Alterations | 44 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Other-ID | 9 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Cohort A-CD: FGFR3 Mutations or Fusions | 100 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A-ID: FGFR3 Mutations or Fusions | 103 | |
| Overall Study | STARTED | Cohort B-ID: All Other FGF/FGFR Alterations | 44 | |
| Overall Study | STARTED | Other-ID | 9 | |
| Overall Study | STARTED | Cohort A-CD: FGFR3 Mutations or Fusions | 101 | |
| Overall Study | STARTED | Other-CD | 3 | |
| Overall Study | COMPLETED | Cohort A-ID: FGFR3 Mutations or Fusions | 10 | |
| Overall Study | COMPLETED | Cohort B-ID: All Other FGF/FGFR Alterations | 2 | |
| Overall Study | COMPLETED | Other-ID | 1 | |
| Overall Study | COMPLETED | Cohort A-CD: FGFR3 Mutations or Fusions | 13 | |
| Overall Study | COMPLETED | Other-CD | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,380
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 pain | Gastrointestinal disorders | Cohort A-ID: FGFR3 Mutations or Fusions | 20 | 103 | 28 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B-ID: All Other FGF/FGFR Alterations | 11 | 44 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Other-ID | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A-CD: FGFR3 Mutations or Fusions | 7 | 101 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Other-CD | 2 | 3 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort A-ID: FGFR3 Mutations or Fusions | 5 | 103 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort B-ID: All Other FGF/FGFR Alterations | 3 | 44 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Other-ID | 0 | 9 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort A-CD: FGFR3 Mutations or Fusions | 6 | 101 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Other-CD | 0 | 3 | 0 |
1 to 10 of 1,380Source ClinicalTrials.gov
See all 1,380 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A-ID: FGFR3 Mutations or Fusions | 88 | 103 |
| Total, all-cause mortality | Cohort B-ID: All Other FGF/FGFR Alterations | 39 | 44 |
| Total, all-cause mortality | Other-ID | 8 | 9 |
| Total, all-cause mortality | Cohort A-CD: FGFR3 Mutations or Fusions | 83 | 101 |
| Total, all-cause mortality | Other-CD | 2 | 3 |
| Total, other adverse events | Cohort A-ID: FGFR3 Mutations or Fusions | 101 | 103 |
| Total, other adverse events | Cohort B-ID: All Other FGF/FGFR Alterations | 43 | 44 |
| Total, other adverse events | Other-ID | 9 | 9 |
| Total, other adverse events | Cohort A-CD: FGFR3 Mutations or Fusions | 99 | 101 |
| Total, other adverse events | Other-CD | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02872714
GET https://conductscience.org/api/trials/v1/NCT02872714/events?page=2