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NCT03037385 · OUTCOME

Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors · Source last updated 2025-05-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
Up to approximately 30.8 months

What was measured

MTD was defined as the highest tolerated dose of pralsetinib without causing dose limiting toxicities (DLTs). DLT was defined as any Grade ≥3 adverse event (AE) occurring during Cycle 1 during Phase 1 (dose escalation) that is not clearly caused by something other than pralsetinib. RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase.

Analysis population: Dose-determining population included all participants in the dose-escalation part who have received ≥75% (21 days) of the study drug and completed safety evaluations through Cycle 1 Day 28 or experienced a DLT.

Groups in this outcome

Phase 1: All Participants QD

Participants received pralsetinib at varying doses at a QD schedule until discontinuation due to toxicity, disease progression, or other reasons.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1: All Participants QD51

Reported measurements

MTD
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: All Participants QD400Not reportedNot reportedNot reportedNot reported
RP2D
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: All Participants QD400Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        400
    title
    MTD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        400
    title
    RP2D
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
MTD was defined as the highest tolerated dose of pralsetinib without causing dose limiting toxicities (DLTs). DLT was defined as any Grade ≥3 adverse event (AE) occurring during Cycle 1 during Phase 1 (dose escalation) that is not clearly caused by something other than pralsetinib. RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase.
groups
  1. description
    Participants received pralsetinib at varying doses at a QD schedule until discontinuation due to toxicity, disease progression, or other reasons.
    id
    OG000
    title
    Phase 1: All Participants QD
param Type
NUMBER
population Description
Dose-determining population included all participants in the dose-escalation part who have received ≥75% (21 days) of the study drug and completed safety evaluations through Cycle 1 Day 28 or experienced a DLT.
reporting Status
POSTED
time Frame
Up to approximately 30.8 months
title
Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib
type
PRIMARY
unit Of Measure
mg

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice