Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

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
Other	Change in T2 hyperintensity baseline assessed by MRI 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
Other	Characterization of serum nirogacestat concentrations assessed in sparse pharmacokinetic (PK) sampling (pre-dose and 1-hour post dose at Cycle 1 Day 1 only) and trough PK sampling (pre-dose at treatment period visits after Cycle 1 Day 1	First day of every 3 cycles (each cycle is 28 days) up to 24 cycles of treatment
Other	Pain severity using Brief Pain Index - Short Form (BPI-SF), question #3	From 7 days prior to date of first dose of treatment through end of Cycle 2 (each cycle is 28 days), assessed up to 9 weeks	BPI question #3 will measure worst pain in the last 24 hours using an 11-point numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine)
Other	Patient experience of desmoid tumors and nirogacestat	One interview will occur following treatment completion (on average approximately 2 years after study entry) and a second interview will occur at study completion (on average approximately 3 years after study entry)	Two (2) optional 60-minute qualitative interviews using open-ended exploratory questions to elicit spontaneous responses will be transcribed and analyzed in an inductive/deductive method to identify themes in the data

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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 list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT07176689/registered

API reference For AI assistants