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NCT03107988 · OUTCOME

Pharmacokinetics A2-Cmax

NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) · Source last updated 2025-09-15

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

Measure
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
Day 15

What was measured

Cmax for lorlatinib in patients in cohort A2

Groups in this outcome

Cohort A2 DL 3A

Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

Cohort A2 DL4A

Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

Cohort A2 DL4A Expansion

Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

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 A2 DL 3A5
Cohort A2 DL4A6
Cohort A2 DL4A Expansion4

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort A2 DL 3A569Not reported3411830Not reported
Cohort A2 DL4A710Not reported502912Not reported
Cohort A2 DL4A Expansion878.5Not reported6021100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        341
        upper Limit
        1830
        value
        569
      2. group Id
        OG001
        lower Limit
        502
        upper Limit
        912
        value
        710
      3. group Id
        OG002
        lower Limit
        602
        upper Limit
        1100
        value
        878.5
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Cmax for lorlatinib in patients in cohort A2
dispersion Type
Full Range
groups
  1. description
    Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    OG000
    title
    Cohort A2 DL 3A
  2. description
    Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    OG001
    title
    Cohort A2 DL4A
  3. description
    Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    OG002
    title
    Cohort A2 DL4A Expansion
param Type
MEDIAN
reporting Status
POSTED
time Frame
Day 15
title
Pharmacokinetics A2-Cmax
type
SECONDARY
unit Of Measure
ng/mL

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

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