NCT03037385 · OUTCOME

Phase 2: t½

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: GEOMETRIC_MEAN
Unit: hours
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days)

What was measured

The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol.

Analysis population: PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Groups in this outcome

RET- Fusion Positive NSCLC Participants

Participants who had RET-fusion positive NSCLC received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. This arm was specifically planned for reporting PK data.

Tumor-agnostic Participants

Participants who had RET-fusion positive NSCLC or TC, or RET-mutation positive MTC, each with different genetic mutations received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.

RET-altered Solid Tumors Participants

Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.

RET-mutation Positive Tumors Other Than MTC Participants

Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. This arm was specifically planned for reporting PK data.

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

Analysis denominator · Participants

Group	Source count
RET- Fusion Positive NSCLC Participants	57
Tumor-agnostic Participants	2
RET-altered Solid Tumors Participants	1
RET-mutation Positive Tumors Other Than MTC Participants	3

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
RET- Fusion Positive NSCLC Participants	57
Tumor-agnostic Participants	2
RET-altered Solid Tumors Participants	1
RET-mutation Positive Tumors Other Than MTC Participants	3

Values in hours · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
RET- Fusion Positive NSCLC Participants	13.4	44.1	Not reported	Not reported	Not reported
Tumor-agnostic Participants	18.4	98.8	Not reported	Not reported	Not reported
RET-altered Solid Tumors Participants	20.8	NA	Not reported	Not reported	Since data was available only for 1 participant geometric co-efficient of variation was not evaluable.
RET-mutation Positive Tumors Other Than MTC Participants	11.0	55.8	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
RET- Fusion Positive NSCLC Participants	47
Tumor-agnostic Participants	2
RET-altered Solid Tumors Participants	1
RET-mutation Positive Tumors Other Than MTC Participants	2

Values in hours · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
RET- Fusion Positive NSCLC Participants	17.9	58.8	Not reported	Not reported	Not reported
Tumor-agnostic Participants	16.5	44.6	Not reported	Not reported	Not reported
RET-altered Solid Tumors Participants	25.8	NA	Not reported	Not reported	Since data was available only for 1 participant geometric co-efficient of variation was not evaluable.
RET-mutation Positive Tumors Other Than MTC Participants	63.0	882	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
44.1
value
13.4
group Id
OG001
spread
98.8
value
18.4
comment
Since data was available only for 1 participant geometric co-efficient of variation was not evaluable.
group Id
OG002
spread
NA
value
20.8
group Id
OG003
spread
55.8
value
11.0
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
58.8
value
17.9
group Id
OG001
spread
44.6
value
16.5
comment
Since data was available only for 1 participant geometric co-efficient of variation was not evaluable.
group Id
OG002
spread
NA
value
25.8
group Id
OG003
spread
882
value
63.0
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
2
units
Participants
title
Cycle 1 Day 15

denoms

counts
group Id
OG000
value
57
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants who had RET-fusion positive NSCLC received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. This arm was specifically planned for reporting PK data.
id
OG000
title
RET- Fusion Positive NSCLC Participants
description
Participants who had RET-fusion positive NSCLC or TC, or RET-mutation positive MTC, each with different genetic mutations received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
id
OG001
title
Tumor-agnostic Participants
description
Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
id
OG002
title
RET-altered Solid Tumors Participants
description
Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. This arm was specifically planned for reporting PK data.
id
OG003
title
RET-mutation Positive Tumors Other Than MTC Participants

param Type

GEOMETRIC_MEAN

population Description

PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

reporting Status

POSTED

time Frame

Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days)

title

Phase 2: t½

type

SECONDARY

unit Of Measure

hours

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Preserved source evidence · Not medical advice