Trial · NCT04197986
Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
NCT04197986, Phase 3, Terminated, QED Therapeutics, a BridgeBio company; results first posted 2024-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations. Trials, record NCT04197986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04197986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
- NCT number
- NCT04197986
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- QED Therapeutics, a BridgeBio company
- Conditions
- Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
- Interventions
- Infigratinib, Placebo
- First posted
- 2019-12-13
- Last updated
- 2024-03-13
- Other registries' IDs
- eudract:2019-003248-63
- Results first posted
- 2024-03-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Centrally Determined Disease-free Survival (DFS) | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, results will focus primarily on the primary and key secondary endpoints of the study. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Secondary | Investigator-assessed DFS | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Secondary | Metastasis-free Survival (MFS) | The time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause. | MFS was defined as the time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause, whichever occurred earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Secondary | Overall Survival (OS) | The number of months from randomization to death. | Overall survival time was defined as the number of months from randomization to death. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Secondary | Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | Investigator assessment of intraluminal low-risk recurrence as assessed by DFS. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Secondary | Number of Participants With Adverse Events (AEs) | From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm). | Number of participants with AEs |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm) | Number of Participants with SAEs |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Centrally Determined Disease-free Survival (DFS) | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | Intent-to-treat (ITT) population, which included all subjects who were randomized | Months | MEDIAN |
| SECONDARY | Investigator-assessed DFS | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | ITT population includes all subjects who were randomized | Months | MEDIAN |
| SECONDARY | Metastasis-free Survival (MFS) | The time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause. | ITT Population | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | The number of months from randomization to death. | ITT population | Months | MEDIAN |
| SECONDARY | Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | ITT population | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm). | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Centrally Determined Disease-free Survival (DFS) | Infigratinib 125 mg | 5.3 | Full Range 0.03 to 17.48 | Months | |
| Centrally Determined Disease-free Survival (DFS) | Placebo | 5.4 | Full Range 0.03 to 20.90 | Months | |
| Investigator-assessed DFS | Infigratinib 125 mg | 6.39 | Full Range 0.03 to 18.07 | Months | |
| Investigator-assessed DFS | Placebo | 12.22 | Full Range 0.03 to 21.36 | Months | |
| Metastasis-free Survival (MFS) | Infigratinib 125 mg | 6.5 | Full Range 0.03 to 18.07 | Months | |
| Metastasis-free Survival (MFS) | Placebo | 12.2 | Full Range 0.03 to 21.36 | Months | |
| Overall Survival (OS) | Infigratinib 125 mg | 13.1 | Full Range 0.76 to 32.07 | Months | |
| Overall Survival (OS) | Placebo | 16.7 | Full Range 1.22 to 31.57 | Months | |
| Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | Infigratinib 125 mg | 5.29 | Full Range 0.03 to 18.07 | Months | |
| Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | Placebo | 5.62 | Full Range 0.03 to 20.90 | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infigratinib 125 mg | 20 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | Treatment Ended | Infigratinib 125 mg | 20 | |
| Overall Study | Treatment Ended | Placebo | 19 | |
| Overall Study | COMPLETED | Infigratinib 125 mg | 20 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Infigratinib 125 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events50
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 | Vision blurred | Eye disorders | Infigratinib 125 mg | 3 | 20 | |
| other | Vision blurred | Eye disorders | Placebo | 2 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | Infigratinib 125 mg | 12 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 19 | |
| other | Dry mouth | Gastrointestinal disorders | Infigratinib 125 mg | 7 | 20 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 19 | |
| other | Abdominal pain | Gastrointestinal disorders | Infigratinib 125 mg | 3 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 19 | |
| other | Constipation | Gastrointestinal disorders | Infigratinib 125 mg | 3 | 20 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 19 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infigratinib 125 mg | 2 | 20 |
| Total, all-cause mortality | Placebo | 1 | 19 |
| Total, other adverse events | Infigratinib 125 mg | 19 | 20 |
| Total, other adverse events | Placebo | 16 | 19 |
| Total, serious adverse events | Infigratinib 125 mg | 2 | 20 |
| Total, serious adverse events | Placebo | 2 | 19 |
Source ClinicalTrials.gov
Papers2
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Infigratinib 125 mg vs Placebo: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| Infigratinib 125 mg vs Placebo: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Infigratinib 125 mg vs Placebo: deaths from any cause | Trial comparisons |
| Infigratinib 125 mg vs Placebo: 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/NCT04197986
GET https://conductscience.org/api/trials/v1/NCT04197986/events?page=2