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Trial · NCT07912398

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryPFS assessed by BIRC (according to Response Assessment in Neuro-Oncology [RANO] 2.0 criteria)Up to approximately 30 monthsPFS(progression-free survival ):The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC(Blinded Independent Review Committee) or death from any cause
SecondaryTTNIUp to approximately 36 monthsTTNI(time to next intervention ):The time from the date of randomization to the date of first initiation of any subsequent anti-tumor therapy or all-cause death
SecondaryTGRevery 6months,up to approximately 30 monthsTGR( tumor growth rate) :The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC or death from any cause
SecondaryTEAEsUp to approximately 30 months
Treatment-emergent adverse events (TEAEs) are defined as all adverse medical events that occur after participants receive the investigational medicinal product, which may manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.
SecondaryPFS assessed by InvestigatorUp to approximately 30 monthsPFS ( progression-free survival) : the time from the date of randomization to the date of first PD confirmed by investigators or all-cause death
SecondaryORRUp to approximately 30 monthsORR(objective response rate),defined as the proportion of participants with best overall response of complete response (CR), partial response (PR), and minor response (MR)
SecondaryDCRUp to approximately 30 monthsDCR(disease control rate), defined as the proportion of participants with best overall response of CR(complete response), PR(partial response), MR(minor response), and SD(Stable Disease )
SecondaryTTRUp to approximately 30 monthsTTR(the time to response), defined as the time from the date of randomization to the date of first documented CR(complete response), PR(partial response), MR(minor response)
SecondaryDoRUp to approximately 30 months
DoR( duration of response), defined as the time from the date of first documented CR(complete response), PR(partial response), MR(minor response) to the date of first documented PD(Disease Progression) or death
Secondary(CR+PR) RateUp to approximately 30 monthsCR+PR rate(the proportion of complete response and partial response), defined as the proportion of participants with best overall response of CR(complete response), and PR(partial response)
SecondaryTime to CR+PRUp to approximately 30 monthsTime to CR+PR, defined as the time from the date of randomization to the date of first documented CR(complete response), or PR(partial response)
SecondaryDuration of CR+PRUp to approximately 30 monthsDuration of CR+PR, defined as the time from the date of first documented CR or PR to the date of first documented PD or death from any cause, whichever occurs first
SecondaryOSUp to approximately 30 monthsOverall survival (OS) :the time from the date of randomization to the date of all-cause death
SecondaryHRQoL (health-related quality of life)assessed by the FACT-Br (Functional Assessment of Cancer Therapy-Brain)questionnaireUp to approximately 30 monthsThe health-related quality of life (HRQoL) will be evaluated using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire in participants treated with HMPL-306 versus placebo
SecondaryPK characteristics(plasma drug concentrations at each sampling time point)Up to approximately 6 monthsPlasma drug concentrations at each sampling time point

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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.

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