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Trial · NCT03037385

Results by group375

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of PralsetinibPhase 1: All Participants QDMTD400mg
Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of PralsetinibPhase 1: All Participants QDRP2D400mg
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib ≤ 300 mg QDAEs37percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib 400 mg QDAEs540percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib BID Dosing ScheduleAEs9percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib All DosesAEs590percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib ≤ 300 mg QDSAEs26percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib 400 mg QDSAEs381percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib BID Dosing ScheduleSAEs7percentage of participants
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)Pralsetinib All DosesSAEs416percentage of participants
Phase 2: Overall Response Rate (ORR)RET- Fusion Positive NSCLC With Prior Platinum Treatment:63.195% Confidence Interval 54.2 to 71.4percentage of participants
Phase 2: Overall Response Rate (ORR)RET-fusion Positive NSCLC With Non-platinum Systemic Treatment73.995% Confidence Interval 51.6 to 89.8percentage of participants
Phase 2: Overall Response Rate (ORR)RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment78.395% Confidence Interval 69.2 to 85.7percentage of participants
Phase 2: Overall Response Rate (ORR)RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment56.795% Confidence Interval 43.2 to 69.4percentage of participants
Phase 2: Overall Response Rate (ORR)RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment77.895% Confidence Interval 66.4 to 86.7percentage of participants
Phase 2: Overall Response Rate (ORR)RET-fusion Positive TC85.295% Confidence Interval 66.3 to 95.8percentage of participants
Phase 2: Overall Response Rate (ORR)RET-fusion Positive Solid Tumors Other Than NSCLC and TC46.495% Confidence Interval 27.5 to 66.1percentage of participants
Phase 2: Overall Response Rate (ORR)RET-altered Solid Tumors Previously Treated With RET Inhibitor19.095% Confidence Interval 5.4 to 41.9percentage of participants
Phase 2: Overall Response Rate (ORR)RET-mutation Positive Tumors Other Than MTC7.795% Confidence Interval 0.99 to 36.0percentage of participants
Phase 1: ORRPhase I: Pralsetinib 30 mg095% Confidence Interval NA to NApercentage of participants

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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