Trial · NCT02924376
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
NCT02924376, Phase 2, Completed, Incyte Corporation; results first posted 2023-02-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202). Trials, record NCT02924376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02924376
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
- NCT number
- NCT02924376
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 147 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Cholangiocarcinoma
- Interventions
- Pemigatinib
- First posted
- 2016-10-05
- Last updated
- 2025-08-14
- Other registries' IDs
- eudract:2016-002422-36
- Results first posted
- 2023-02-23
Source ClinicalTrials.gov
Registered outcomes13
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 FGFR2 Rearrangements or Fusions | up to 1527 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee. |
| Secondary | ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | up to 424 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee. |
| Secondary | ORR in All Participants With FGF/FGFR Alterations | up to 1527 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee. |
| Secondary | ORR in Participants Negative for FGF/FGFR Alterations | up to 143 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee. |
| Secondary | Progression-free Survival (PFS) | up to 50.17 months | PFS was defined as the length of time from the first dose of 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 47.11 months | DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee 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. PD: progression of a target or non-target lesion or presence of a new lesion. |
| Secondary | Disease Control Rate (DCR) | up to 1527 days | DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. |
| Secondary | Overall Survival | up to 51.32 months | Overall survival was defined as the length of time from the first dose of study drug (Day 1) until the date of death due to any cause. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 1584 days | 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 defined as any adverse event 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 | First-order Absorption Rate Constant (ka) of Pemigatinib | Predose; 1-2 hours post-dose; 4-12 hours post-dose | First-order absorption rate constant is defined as the rate at which a drug enters into the system. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 FGFR2 Rearrangements or Fusions | up to 1527 days | Efficacy Evaluable Population (EEP): all participants who received ≥1 dose of pemigatinib and had a known FGF/FGFR alteration or, in the United States, were negative for FGF/FGFR alterations based on central genomics laboratory results. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | up to 424 days | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in All Participants With FGF/FGFR Alterations | up to 1527 days | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in Participants Negative for FGF/FGFR Alterations | up to 143 days | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | up to 50.17 months | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | up to 47.11 months | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | up to 1527 days | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | up to 51.32 months | Efficacy Evaluable Population. Two participants were assigned to a group labeled Other and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 1584 days | Safety Population: all enrolled participants who received at least 1 dose of pemigatinib | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | First-order Absorption Rate Constant (ka) of Pemigatinib | Predose; 1-2 hours post-dose; 4-12 hours post-dose | Pharmacokinetic (PK) Population: all participants contributing at least one sample for PK analysis | 1/hour | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group22
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 FGFR2 Rearrangements or Fusions | Cohort A: FGFR2 Rearrangements or Fusions | 37.0 | 95% Confidence Interval 27.94 to 46.86 | percentage of participants | |
| ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 0.0 | 95% Confidence Interval 0.0 to 16.84 | percentage of participants | |
| ORR in All Participants With FGF/FGFR Alterations | Cohort A + Cohort B | 31.3 | 95% Confidence Interval 23.35 to 40.04 | percentage of participants | |
| ORR in Participants Negative for FGF/FGFR Alterations | Cohort C: Negative for FGF/FGFR Alterations | 0.0 | 95% Confidence Interval 0.0 to 19.51 | percentage of participants | |
| Progression-free Survival (PFS) | Cohort A: FGFR2 Rearrangements or Fusions | 7.03 | 95% Confidence Interval 6.08 to 10.48 | months | |
| Progression-free Survival (PFS) | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 2.10 | 95% Confidence Interval 1.18 to 4.86 | months | |
| Progression-free Survival (PFS) | Cohort C: Negative for FGF/FGFR Alterations | 1.51 | 95% Confidence Interval 1.38 to 1.84 | months | |
| Duration of Response (DOR) | Cohort A: FGFR2 Rearrangements or Fusions | 9.13 | 95% Confidence Interval 6.01 to 14.49 | months | |
| Disease Control Rate (DCR) | Cohort A: FGFR2 Rearrangements or Fusions | 82.4 | 95% Confidence Interval 73.9 to 89.1 | percentage of participants | |
| Disease Control Rate (DCR) | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 40.0 | 95% Confidence Interval 19.1 to 63.9 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: FGFR2 Rearrangements or Fusions | 108 | |
| Overall Study | STARTED | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 20 | |
| Overall Study | STARTED | Cohort C: Negative for FGF/FGFR Alterations | 17 | |
| Overall Study | STARTED | Other | 2 | |
| Overall Study | COMPLETED | Cohort A: FGFR2 Rearrangements or Fusions | 0 | |
| Overall Study | COMPLETED | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 0 | |
| Overall Study | COMPLETED | Cohort C: Negative for FGF/FGFR Alterations | 0 | |
| Overall Study | COMPLETED | Other | 0 | |
| Overall Study | NOT COMPLETED | Cohort A: FGFR2 Rearrangements or Fusions | 108 | |
| Overall Study | NOT COMPLETED | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,375
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: FGFR2 Rearrangements or Fusions | 9 | 108 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 0 | 20 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Cohort C: Negative for FGF/FGFR Alterations | 1 | 17 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Other | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Total | 10 | 147 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A: FGFR2 Rearrangements or Fusions | 22 | 108 | 39 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 3 | 20 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort C: Negative for FGF/FGFR Alterations | 3 | 17 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Other | 1 | 2 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Total | 29 | 147 | 46 |
1 to 10 of 1,375Source ClinicalTrials.gov
See all 1,375 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: FGFR2 Rearrangements or Fusions | 76 | 108 |
| Total, all-cause mortality | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 18 | 20 |
| Total, all-cause mortality | Cohort C: Negative for FGF/FGFR Alterations | 15 | 17 |
| Total, all-cause mortality | Other | 2 | 2 |
| Total, all-cause mortality | Total | 111 | 147 |
| Total, other adverse events | Cohort A: FGFR2 Rearrangements or Fusions | 108 | 108 |
| Total, other adverse events | Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 20 | 20 |
| Total, other adverse events | Cohort C: Negative for FGF/FGFR Alterations | 17 | 17 |
| Total, other adverse events | Other | 2 | 2 |
| Total, other adverse events | Total | 147 | 147 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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/NCT02924376
GET https://conductscience.org/api/trials/v1/NCT02924376/results?page=2