NCT03037385 · OUTCOME

Phase 2: Cmax

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: ng/mL
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)

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.

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.

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	98
Tumor-agnostic Participants	5
RET-altered Solid Tumors Participants	3
RET-mutation Positive Tumors Other Than MTC Participants	4

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
RET- Fusion Positive NSCLC Participants	98
Tumor-agnostic Participants	5
RET-altered Solid Tumors Participants	3
RET-mutation Positive Tumors Other Than MTC Participants	4

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
RET- Fusion Positive NSCLC Participants	1680	69.4	Not reported	Not reported	Not reported
Tumor-agnostic Participants	1380	65.4	Not reported	Not reported	Not reported
RET-altered Solid Tumors Participants	2450	164	Not reported	Not reported	Not reported
RET-mutation Positive Tumors Other Than MTC Participants	1770	87.2	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
RET- Fusion Positive NSCLC Participants	87
Tumor-agnostic Participants	5
RET-altered Solid Tumors Participants	3
RET-mutation Positive Tumors Other Than MTC Participants	4

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
RET- Fusion Positive NSCLC Participants	2840	50.7	Not reported	Not reported	Not reported
Tumor-agnostic Participants	2200	36.7	Not reported	Not reported	Not reported
RET-altered Solid Tumors Participants	3440	93.9	Not reported	Not reported	Not reported
RET-mutation Positive Tumors Other Than MTC Participants	2430	55.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
69.4
value
1680
group Id
OG001
spread
65.4
value
1380
group Id
OG002
spread
164
value
2450
group Id
OG003
spread
87.2
value
1770
denoms
counts
group Id
OG000
value
98
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
50.7
value
2840
group Id
OG001
spread
36.7
value
2200
group Id
OG002
spread
93.9
value
3440
group Id
OG003
spread
55.3
value
2430
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
units
Participants
title
Cycle 1 Day 15

denoms

counts
group Id
OG000
value
98
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
units
Participants

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.
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.
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: Cmax

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice