Trial · NCT04228042
Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer
NCT04228042, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2025-01-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer. Trials, record NCT04228042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04228042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer
- NCT number
- NCT04228042
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Renal Pelvis and Ureter Urothelial Carcinoma
- Interventions
- Infigratinib, Quality-of-Life Assessment, Questionnaire Administration, Surgical Procedure
- First posted
- 2020-01-14
- Last updated
- 2025-01-01
- Results first posted
- 2025-01-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability - TOX Rate | From day 1 until 30 days following last dose of infigratinib or until surgery, whichever occurs last, up to a total of 3 months. | The study will estimate percentage of patients who are not able to complete treatment (discontinuation) due to excessive toxicity along with the 90% exact confidence interval (NOTE: excessive toxicity is defined as treatment related adverse events that cause patients not to complete 2-cycles of planned treatment schedule, or delay in planned surgery greater than 14 days) |
| Secondary | Evaluate the Objective Response Rate (CR+PR) of Infigratinib After 2 Cycles in UTUC With and Without FGFR3alterations | Efficacy will be measured at time of surgery or approximately 2 months | Percentage of patients achieving a point in time objective response (either complete or partial response \[CR or PR\]) after 2 cycles of infigratinib. Tumor mapping will be performed from the endoscopic evaluation (after any biopsies) and this will be used to compare to pathologic (NUx/Ux cohort) or ureteroscopic (endoscopy cohort) findings in order to determine responses. Tumor mapping will be performed based on endoscopic findings, noting location, number of tumors, tumor architecture, and location of biopsies; and will again be performed during pathologic evaluation again noting size, location, number of tumors, architecture, and absence of tumor at any previously identified tumor. A difference of 3mm will be considered within error of measurement. All analyses will be performed on patients stratified as having or not having FGFR3 alterations. |
| Secondary | To Evaluate Patient-reported Quality of Life (QOL) | QoL surveys were obtained at baseline (day 1), pre-op after having received infigratinib for 2 cycles and 30 days after surgery, up to 3 months | Categorical variables were tabulated with frequency and percentage; continuous variables were summarized using descriptive statistics. A linear transformation to standardize the raw score was calculated for Functional/symptom scales and global health status (QOL) using the guidance in Scoring the EORTC QLQ-C30 version 3.0, so that scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. Wilcoxon signed rank test was applied to compare functional/symptom scales and global health status (QOL) between different time points. A higher score for symptoms represents a worse outcome. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability - TOX Rate | From day 1 until 30 days following last dose of infigratinib or until surgery, whichever occurs last, up to a total of 3 months. | All patients who received at least one dose of infigratinib and completed surgery were included in the anlaysis. There were no delays to planned surgery in any of the participants | percentage of patients | NUMBER |
| SECONDARY | Evaluate the Objective Response Rate (CR+PR) of Infigratinib After 2 Cycles in UTUC With and Without FGFR3alterations | Efficacy will be measured at time of surgery or approximately 2 months | percentage of participants | NUMBER | |
| SECONDARY | To Evaluate Patient-reported Quality of Life (QOL) | QoL surveys were obtained at baseline (day 1), pre-op after having received infigratinib for 2 cycles and 30 days after surgery, up to 3 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability - TOX Rate | Infigratinib Plus Surgery | 14.30 | 90% Confidence Interval 2.6 to 38.5 | percentage of patients | |
| Evaluate the Objective Response Rate (CR+PR) of Infigratinib After 2 Cycles in UTUC With and Without FGFR3alterations | Infigratinib Plus Surgery | 66.7 | 90% Confidence Interval 34.5 to 90.2 | percentage of participants | |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Fatigue score: Pre-OP | 17.46 | Standard Deviation 12.1 | score on a scale |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Fatigue score: post-OP | 15.08 | Standard Deviation 20.26 | score on a scale |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Score of diarrhea: At screening | 12.82 | Standard Deviation 21.68 | score on a scale |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Score of diarrhea: Pre-OP | 12.80 | Standard Deviation 16.88 | score on a scale |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Scores of appetite loss: At screening | 4.76 | Standard Deviation 12.1 | score on a scale |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Scores of appetite loss: Pre-OP | 19.05 | Standard Deviation 21.54 | score on a scale |
| To Evaluate Patient-reported Quality of Life (QOL) | Infigratinib Plus Surgery | Scores of appetite loss: 30 days Post-OP | 7.14 | Standard Deviation 14.19 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infigratinib Plus Surgery | 14 | |
| Overall Study | COMPLETED | Infigratinib Plus Surgery | 14 | |
| Overall Study | NOT COMPLETED | Infigratinib Plus Surgery | 0 |
Source ClinicalTrials.gov
Adverse events40
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 | Hyperphosphatemia | Investigations | Infigratinib Plus Surgery | 9 | 14 | 9 |
| other | Hyponatremia | Investigations | Infigratinib Plus Surgery | 2 | 14 | 2 |
| other | Lipase Increase | Investigations | Infigratinib Plus Surgery | 3 | 14 | 3 |
| other | Amylase Increase | Investigations | Infigratinib Plus Surgery | 2 | 14 | 2 |
| other | Hyperkalemia | Investigations | Infigratinib Plus Surgery | 2 | 14 | 2 |
| other | Creatinine Increase | Investigations | Infigratinib Plus Surgery | 2 | 14 | 2 |
| other | BUN Increase | Investigations | Infigratinib Plus Surgery | 1 | 14 | 1 |
| other | Cytokine Release Syndrome | Investigations | Infigratinib Plus Surgery | 1 | 14 | 1 |
| other | Anemia | Investigations | Infigratinib Plus Surgery | 1 | 14 | 1 |
| other | Hypercalcemia | Investigations | Infigratinib Plus Surgery | 1 | 14 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infigratinib Plus Surgery | 0 | 14 |
| Total, other adverse events | Infigratinib Plus Surgery | 12 | 14 |
| Total, serious adverse events | Infigratinib Plus Surgery | 1 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38573872 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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/NCT04228042
GET https://conductscience.org/api/trials/v1/NCT04228042/events?page=2