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NCT03157128 · OUTCOME

Phase 1: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax)

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) · Source last updated 2026-04-16

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

Measure
GEOMETRIC_MEAN
Unit
nanogram per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days)

Analysis population: All Participants who received at least 1 or more doses of selpercatinib and had PK evaluable data for this outcome.

Groups in this outcome

Phase 1: 20 mg Selpercatinib QD

Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 20 mg Selpercatinib BID

Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 40 mg Selpercatinib BID

Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 60 mg Selpercatinib BID

Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 160 mg Selpercatinib QD

Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 80 mg Selpercatinib BID

Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 120 mg Selpercatinib BID

Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 160 mg Selpercatinib BID

Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 200 mg Selpercatinib BID

Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.

Phase 1: 240 mg Selpercatinib BID

Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for 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: 20 mg Selpercatinib QD4
Phase 1: 20 mg Selpercatinib BID9
Phase 1: 40 mg Selpercatinib BID12
Phase 1: 60 mg Selpercatinib BID11
Phase 1: 160 mg Selpercatinib QD0
Phase 1: 80 mg Selpercatinib BID15
Phase 1: 120 mg Selpercatinib BID10
Phase 1: 160 mg Selpercatinib BID486
Phase 1: 200 mg Selpercatinib BID2
Phase 1: 240 mg Selpercatinib BID3

Reported measurements

Source class 1
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: 20 mg Selpercatinib QD22014Not reportedNot reportedNot reported
Phase 1: 20 mg Selpercatinib BID27553Not reportedNot reportedNot reported
Phase 1: 40 mg Selpercatinib BID52855Not reportedNot reportedNot reported
Phase 1: 60 mg Selpercatinib BID104046Not reportedNot reportedNot reported
Phase 1: 80 mg Selpercatinib BID125045Not reportedNot reportedNot reported
Phase 1: 120 mg Selpercatinib BID268027Not reportedNot reportedNot reported
Phase 1: 160 mg Selpercatinib BID308048Not reportedNot reportedNot reported
Phase 1: 200 mg Selpercatinib BIDNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated as there were only two participants. Individual values reported: 3760 ng/mL;1630 ng/mL.
Phase 1: 240 mg Selpercatinib BID513017Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14
        value
        220
      2. group Id
        OG001
        spread
        53
        value
        275
      3. group Id
        OG002
        spread
        55
        value
        528
      4. group Id
        OG003
        spread
        46
        value
        1040
      5. group Id
        OG005
        spread
        45
        value
        1250
      6. group Id
        OG006
        spread
        27
        value
        2680
      7. group Id
        OG007
        spread
        48
        value
        3080
      8. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated as there were only two participants. Individual values reported: 3760 ng/mL;1630 ng/mL.
        group Id
        OG008
        spread
        NA
        value
        NA
      9. group Id
        OG009
        spread
        17
        value
        5130
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      15
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      486
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      3
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG000
    title
    Phase 1: 20 mg Selpercatinib QD
  2. description
    Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG001
    title
    Phase 1: 20 mg Selpercatinib BID
  3. description
    Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG002
    title
    Phase 1: 40 mg Selpercatinib BID
  4. description
    Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG003
    title
    Phase 1: 60 mg Selpercatinib BID
  5. description
    Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG004
    title
    Phase 1: 160 mg Selpercatinib QD
  6. description
    Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG005
    title
    Phase 1: 80 mg Selpercatinib BID
  7. description
    Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG006
    title
    Phase 1: 120 mg Selpercatinib BID
  8. description
    Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG007
    title
    Phase 1: 160 mg Selpercatinib BID
  9. description
    Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG008
    title
    Phase 1: 200 mg Selpercatinib BID
  10. description
    Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
    id
    OG009
    title
    Phase 1: 240 mg Selpercatinib BID
param Type
GEOMETRIC_MEAN
population Description
All Participants who received at least 1 or more doses of selpercatinib and had PK evaluable data for this outcome.
reporting Status
POSTED
time Frame
Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days)
title
Phase 1: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax)
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Independent clinical review pending · Not medical advice