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NCT03157128 · OUTCOME

Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 28 days

What was measured

Phase 1: Number of Participants with a TRAE(s) is reported.

Analysis population: All Participants who received at least 1 or more doses of selpercatinib and had 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 QD6
Phase 1: 20 mg Selpercatinib BID10
Phase 1: 40 mg Selpercatinib BID16
Phase 1: 60 mg Selpercatinib BID12
Phase 1: 160 mg Selpercatinib QD1
Phase 1: 80 mg Selpercatinib BID20
Phase 1: 120 mg Selpercatinib BID19
Phase 1: 160 mg Selpercatinib BID764
Phase 1: 200 mg Selpercatinib BID3
Phase 1: 240 mg Selpercatinib BID6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: 20 mg Selpercatinib QD3Not reportedNot reportedNot reportedNot reported
Phase 1: 20 mg Selpercatinib BID9Not reportedNot reportedNot reportedNot reported
Phase 1: 40 mg Selpercatinib BID14Not reportedNot reportedNot reportedNot reported
Phase 1: 60 mg Selpercatinib BID12Not reportedNot reportedNot reportedNot reported
Phase 1: 160 mg Selpercatinib QD1Not reportedNot reportedNot reportedNot reported
Phase 1: 80 mg Selpercatinib BID18Not reportedNot reportedNot reportedNot reported
Phase 1: 120 mg Selpercatinib BID17Not reportedNot reportedNot reportedNot reported
Phase 1: 160 mg Selpercatinib BID733Not reportedNot reportedNot reportedNot reported
Phase 1: 200 mg Selpercatinib BID3Not reportedNot reportedNot reportedNot reported
Phase 1: 240 mg Selpercatinib BID6Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        18
      7. group Id
        OG006
        value
        17
      8. group Id
        OG007
        value
        733
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      16
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      20
    7. group Id
      OG006
      value
      19
    8. group Id
      OG007
      value
      764
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      6
    units
    Participants
description
Phase 1: Number of Participants with a TRAE(s) is reported.
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
COUNT_OF_PARTICIPANTS
population Description
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
reporting Status
POSTED
time Frame
Up to 28 days
title
Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])
type
SECONDARY
unit Of Measure
Participants

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

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