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Trial · NCT06333951

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants Experiencing Dose Limiting Toxicities (DLT)Up to approximately 21 days
PrimaryNumber of Participants Experiencing Treatment Emergent Adverse Events (TEAE)Up to approximately 3 years
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
PrimaryNumber of Participants Experiencing Serious Adverse Events (SAE)Up to approximately 3 years
An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
SecondaryObjective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)Up to approximately 3 years
SecondaryDisease Control (DC) per RECIST v1.1Up to approximately 3 years
SecondaryDuration of Response (DOR) per RECIST v1.1Up to approximately 3 years
SecondaryTime to Response (TTR) per RECIST v1.1Up to approximately 3 years
SecondaryOverall Survival (OS) per RECIST v1.1Up to approximately 3 years
SecondaryProgression-free Survival (PFS) per RECIST v1.1Up to approximately 3 years
SecondaryMaximum Plasma Concentration (Cmax) of AnvumetostatUp to Day 1 of Cycle 5 (one cycle = 21 days)
SecondaryTime to Maximum Plasma Concentration (tmax) of AnvumetostatUp to Day 1 of Cycle 5 (one cycle = 21 days)
SecondaryArea Under the Plasma Concentration-time Curve (AUC) of AnvumetostatUp to Day 1 of Cycle 5 (one cycle = 21 days)
SecondaryIntracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )Up to approximately 3 years
SecondaryIntracranial Disease Control (IDC) per RANO-BMUp to approximately 3 years
SecondaryIntracranial Duration of Response (IDOR) per RANO-BMUp to approximately 3 years
SecondaryTime to Intracranial Radiation Therapy per RANO-BMUp to approximately 3 years

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.

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