Trial · NCT05236257
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
NCT05236257, Completed, Bayer; results first posted 2024-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database. Trials, record NCT05236257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05236257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
- NCT number
- NCT05236257
- Status
- Completed
- Enrollment
- 93 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion, Infantile Fibrosarcoma
- Interventions
- Larotrectinib (Vitrakvi, BAY2757556), Standard of Care
- First posted
- 2022-02-11
- Last updated
- 2024-12-10
- Results first posted
- 2024-12-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Medical Treatment Failure | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Time to medical treatment failure was defined as the time (months) from the start of treatment to the date of the earliest event from: subsequent systemic treatment, radiation therapy, mutilating surgery or death due to any cause. |
| Secondary | Time to Subsequent Systemic Treatment | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Time to subsequent systemic treatment was defined as the time from start date of Larotrectinib (for SCOUT) or start date of chemotherapy (for historical control cohorts) till the start date of a post-treatment systemic anti-cancer therapy, if any |
| Secondary | Time to Mutilating Surgery Including Limb Amputation | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Time to mutilating surgery including limb amputation was defined as the time from start date of Larotrectinib (for SCOUT) or start date of chemotherapy (for historical control cohorts) till the start date of a mutilating surgery (including limb amputation) |
| Secondary | Time to First Radiation Therapy | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Time to radiation therapy was defined as the time from start date of Larotrectinib (for SCOUT) or start date of chemotherapy(for historical control cohorts) till the start date of a radiation therapy, if any |
| Secondary | Time to Complete Surgical Resection | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Time to complete surgical resection (excluding amputation) was defined as the time from start date of Larotrectinib (for SCOUT) or start date of chemotherapy (for historical control cohorts) till the start date of a complete surgical resection (excluding amputation), if any |
| Secondary | Overall Survival | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Number of participants with death due to any cause, alive, or lost to follow-up. |
| Secondary | Number of Participants With Treatment Discontinuation Due to Treatment Emergent Adverse Events | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Larotrectinib treatment for the SCOUT study and chemotherapy (first line) for the external historical control cohort(s). |
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 | Time to Medical Treatment Failure | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | months | MEDIAN | |
| SECONDARY | Time to Subsequent Systemic Treatment | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | months | MEDIAN | |
| SECONDARY | Time to Mutilating Surgery Including Limb Amputation | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | months | MEDIAN | |
| SECONDARY | Time to First Radiation Therapy | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | months | MEDIAN | |
| SECONDARY | Time to Complete Surgical Resection | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | months | MEDIAN | |
| SECONDARY | Overall Survival | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Treatment Discontinuation Due to Treatment Emergent Adverse Events | up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Medical Treatment Failure | Larotrectinib | Unweighted sample | NA | 95% Confidence Interval NA to NA | months |
| Time to Medical Treatment Failure | External Controls | Unweighted sample | NA | 95% Confidence Interval 57.1 to NA | months |
| Time to Medical Treatment Failure | Larotrectinib | Weighted sample | NA | 95% Confidence Interval NA to NA | months |
| Time to Medical Treatment Failure | External Controls | Weighted sample | 24.0 | 95% Confidence Interval 3.0 to NA | months |
| Time to Subsequent Systemic Treatment | Larotrectinib | Unweighted Sample | NA | 95% Confidence Interval NA to NA | months |
| Time to Subsequent Systemic Treatment | External Controls | Unweighted Sample | NA | 95% Confidence Interval 13.0 to NA | months |
| Time to Subsequent Systemic Treatment | Larotrectinib | weighted Sample | NA | 95% Confidence Interval NA to NA | months |
| Time to Subsequent Systemic Treatment | External Controls | weighted Sample | 24.0 | 95% Confidence Interval 24.0 to NA | months |
| Time to Mutilating Surgery Including Limb Amputation | Larotrectinib | Unweighted Sample | NA | 95% Confidence Interval NA to NA | months |
| Time to Mutilating Surgery Including Limb Amputation | External Controls | Unweighted Sample | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Larotrectinib | 51 | |
| Overall Study | STARTED | External Controls | 42 | |
| Overall Study | COMPLETED | Larotrectinib | 0 | |
| Overall Study | COMPLETED | External Controls | 0 | |
| Overall Study | NOT COMPLETED | Larotrectinib | 51 | |
| Overall Study | NOT COMPLETED | External Controls | 42 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | Larotrectinib | 1 | 51 | 1 |
| serious | Death | General disorders | External Controls | 3 | 42 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Larotrectinib | 1 | 51 |
| Total, all-cause mortality | External Controls | 3 | 42 |
| Total, other adverse events | Larotrectinib | 0 | 51 |
| Total, other adverse events | External Controls | 0 | 42 |
| Total, serious adverse events | Larotrectinib | 1 | 51 |
| Total, serious adverse events | External Controls | 3 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37133249 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Larotrectinib vs External Controls: deaths from any cause | Trial comparisons |
| Larotrectinib vs External Controls: Number of Participants With Treatment Discontinuation Due to Treatment Emergent Adverse Events | Trial comparisons |
| Larotrectinib vs External Controls: 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/NCT05236257
GET https://conductscience.org/api/trials/v1/NCT05236257/results?page=2