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NCT01139775 · OUTCOME

Phase 1: Pharmacokinetic: Maximum Plasma Concentration (Cmax) (LY2603618)

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

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
Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose

What was measured

Cmax is reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.

Analysis population: Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.

Groups in this outcome

Phase 1: Pemetrexed + Cisplatin + LY2603618

Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

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: Pemetrexed + Cisplatin + LY260361813

Reported measurements

130 mg, Cycle 1/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618181014Not reportedNot reportedNot reported
130 mg, Cycle 2/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618173043Not reportedNot reportedNot reported
185 mg, Cycle 1/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618220033Not reportedNot reportedNot reported
185 mg, Cycle 2/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618219058Not reportedNot reportedNot reported
240 mg, Cycle 1/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618347027Not reportedNot reportedNot reported
240 mg, Cycle 2/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618275063Not reportedNot reportedNot reported
275 mg, Cycle 1/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036183
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618413029Not reportedNot reportedNot reported
275 mg, Cycle 2/Day 2

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY26036184
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY2603618362023Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14
        value
        1810
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    130 mg, Cycle 1/Day 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        43
        value
        1730
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    130 mg, Cycle 2/Day 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        33
        value
        2200
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    185 mg, Cycle 1/Day 2
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        58
        value
        2190
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    185 mg, Cycle 2/Day 2
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        3470
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    240 mg, Cycle 1/Day 2
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        63
        value
        2750
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    240 mg, Cycle 2/Day 2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        29
        value
        4130
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    275 mg, Cycle 1/Day 2
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        23
        value
        3620
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    275 mg, Cycle 2/Day 2
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Cmax is reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    OG000
    title
    Phase 1: Pemetrexed + Cisplatin + LY2603618
param Type
GEOMETRIC_MEAN
population Description
Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.
reporting Status
POSTED
time Frame
Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose
title
Phase 1: Pharmacokinetic: Maximum Plasma Concentration (Cmax) (LY2603618)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice