Trial · NCT07176689
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
NCT07176689, Phase 4, Recruiting, SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF). Trials, record NCT07176689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07176689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
- NCT number
- NCT07176689
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 50 participants, estimated
- Lead sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
- Conditions
- Desmoid Tumor, Aggressive Fibromatosis
- Interventions
- Nirogacestat
- First posted
- 2025-09-16
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ovarian function recovery rate of ovarian toxicity (OT) treatment-emergent adverse events (TEAEs) | Up to 24 cycles (each cycle is 28 days) of treatment and up to 2 years in the Clinical Follow-up Period | Ovarian function recovery is defined as achieving the resumption of ≥2 consecutive menstrual periods and an FSH level \<30 mIU/mL with concomitant estradiol \<80 pg/mL OR resumption of ≥2 consecutive menstrual periods and AMH level within normal range adjusted for age and pretreatment baseline OR a positive serum β-HCG pregnancy test. |
| Secondary | Incidence of OT TEAEs | Up to 24 cycles (each cycle is 28 days) of treatment and up to 2 years in the Clinical Follow-up Period | OT is any new onset amenorrhea lasting ≥3 consecutive menstrual periods, FSH level ≥30 mIU/mL and a negative β-HCG pregnancy test. |
| Secondary | Time to ovarian function recovery in participants with a TEAE of OT | Up to 24 cycles (each cycle is 28 days) of treatment and up to 2 years in the Clinical Follow-up Period | Time to ovarian function recovery is evaluated in participants who had a TEAE of OT and is defined as the time it takes to resolve. |
| Secondary | The incidence of adverse events (AEs) according to toxicities graded by National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) Version 5 | Up to 24 cycles (each cycle is 28 days) of treatment and up to 2 years in the Clinical Follow-up Period | |
| Other | Objective Response Rate (ORR) | First day of every 3 cycles (each cycle is 28 days) for up to 24 cycles of treatment and up to 1 year in the Clinical Follow-up Period | Proportion of participants with Complete Response (CR) and Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria |
| Other | Duration of Response (DoR) for participants whose best response is CR or PR | First day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, up to 24 cycles of treatment and up to 1 year in the Clinical Follow-up Period | DoR is defined as the duration from the time of first assessment of CR or PR response (per RECIST v1.1) to the first date of disease progression or death (whichever comes first). |
| Other | Disease Control Rate (DCR) for participants whose best response is CR, PR or Stable Disease (SD) | First day of every 3 cycles (each cycle is 28 days) for up to 24 cycles of treatment and up to 1 year in the Clinical Follow-up Period | DCR is defined as the proportion of participants who have a best response of CR, PR, or SD. |
| Other | Duration of Disease Control (DoDC) for participants whose best response is CR, PR or SD | First day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, up to 24 cycles of treatment and up to 1 year in the Clinical Follow-up Period | DoDC is defined as the duration from the start of study treatment until first date of disease progression or death (whichever comes first). |
| Other | Progression Free Survival (PFS) | First day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, up to 24 cycles of treatment and up to 1 year in the Clinical Follow-up Period | PFS is defined at the start of study treatment until the date of assessment of progression or death by any cause. Progression will be determined radiographically using RESIST v1.1 performed by a local radiologist. |
| Other | Changes in tumor volume from baseline assessed by MRI volumetric analysis performed locally | First day of every 3 cycles (each cycle is 28 days) up to 24 cycles and up to 1 year in the Clinical Follow-up Period |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07176689
GET https://conductscience.org/api/trials/v1/NCT07176689/registered