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NCT04148937 · OUTCOME

Number of Participants With Dose Limiting Toxicities (DLTs)

A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer · Source last updated 2024-04-05

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 from the first dose

What was measured

A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) version 5.0: * Grade 3 thrombocytopenia associated with clinically significant bleeding and requiring platelet transfusion or Grade 4 thrombocytopenia of any duration. * Grade ≥3 febrile neutropenia * Grade ≥3 anemia requiring a blood transfusion * Other Grade ≥4 toxicities, excluding few nonhematologic Toxicities * Any other significant toxicity deemed by the investigatory to be dose-limiting, such as: any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during 28-day DLT observation period), persistent Grade \>2 toxicities causing a delay of LY3475070 study treatment \>14 days during the 28-day DLT observation period.

Analysis population: All participants enrolled in the phase 1a who either completed 28 days of follow-up and at least 75% of LY3475070 treatment doses or discontinued treatment prior to 28 days due to a DLT.

Groups in this outcome

Cohort A - 150mg QD LY3475070

Participants received 150mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort A - 300mg QD LY3475070

Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort A - 300mg BID LY3475070

Participants received 300mg LY3475070 orally twice daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort A - 600mg QD LY3475070

Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 150mg QD LY3475070 + Pembrolizumab

Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 150mg BID LY3475070 + Pembrolizumab

Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 300mg QD LY3475070 + Pembrolizumab

Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 300mg BID LY3475070 + Pembrolizumab

Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study

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

Analysis denominator · Participants

GroupSource count
Cohort A - 150mg QD LY34750704
Cohort A - 300mg QD LY34750706
Cohort A - 300mg BID LY34750706
Cohort A - 600mg QD LY34750704
Cohort B - 150mg QD LY3475070 + Pembrolizumab3
Cohort B - 150mg BID LY3475070 + Pembrolizumab11
Cohort B - 300mg QD LY3475070 + Pembrolizumab1
Cohort B - 300mg BID LY3475070 + Pembrolizumab17

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A - 150mg QD LY34750700Not reportedNot reportedNot reportedNot reported
Cohort A - 300mg QD LY34750700Not reportedNot reportedNot reportedNot reported
Cohort A - 300mg BID LY34750700Not reportedNot reportedNot reportedNot reported
Cohort A - 600mg QD LY34750700Not reportedNot reportedNot reportedNot reported
Cohort B - 150mg QD LY3475070 + Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Cohort B - 150mg BID LY3475070 + Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Cohort B - 300mg QD LY3475070 + Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Cohort B - 300mg BID LY3475070 + Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      17
    units
    Participants
description
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) version 5.0: * Grade 3 thrombocytopenia associated with clinically significant bleeding and requiring platelet transfusion or Grade 4 thrombocytopenia of any duration. * Grade ≥3 febrile neutropenia * Grade ≥3 anemia requiring a blood transfusion * Other Grade ≥4 toxicities, excluding few nonhematologic Toxicities * Any other significant toxicity deemed by the investigatory to be dose-limiting, such as: any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during 28-day DLT observation period), persistent Grade \>2 toxicities causing a delay of LY3475070 study treatment \>14 days during the 28-day DLT observation period.
groups
  1. description
    Participants received 150mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG000
    title
    Cohort A - 150mg QD LY3475070
  2. description
    Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG001
    title
    Cohort A - 300mg QD LY3475070
  3. description
    Participants received 300mg LY3475070 orally twice daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG002
    title
    Cohort A - 300mg BID LY3475070
  4. description
    Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG003
    title
    Cohort A - 600mg QD LY3475070
  5. description
    Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG004
    title
    Cohort B - 150mg QD LY3475070 + Pembrolizumab
  6. description
    Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG005
    title
    Cohort B - 150mg BID LY3475070 + Pembrolizumab
  7. description
    Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG006
    title
    Cohort B - 300mg QD LY3475070 + Pembrolizumab
  8. description
    Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study
    id
    OG007
    title
    Cohort B - 300mg BID LY3475070 + Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants enrolled in the phase 1a who either completed 28 days of follow-up and at least 75% of LY3475070 treatment doses or discontinued treatment prior to 28 days due to a DLT.
reporting Status
POSTED
time Frame
Up to 28 days from the first dose
title
Number of Participants With Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice