Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01139775 · OUTCOME

Phase 2: Pharmacokinetic: AUC (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*h/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1/Day 2 - predose, immediately prior to the end of the LY2603618 infusion, and 2-6, 24-48, and 72-96 hours postdose

What was measured

AUC (0-24), AUC(0-tlast), and AUC(0-∞) values are reported for LY2603618. The number of pharmacokinetic observations (n) used in the analysis is presented.

Analysis population: Phase 2 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.

Groups in this outcome

Phase 2: Pemetrexed + Cisplatin + LY2603618

Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. 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 2: Pemetrexed + Cisplatin + LY260361833

Reported measurements

AUC (0-24)

Analysis denominator · Participants

GroupSource count
Phase 2: Pemetrexed + Cisplatin + LY260361832
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 2: Pemetrexed + Cisplatin + LY26036183140049Not reportedNot reportedNot reported
AUC (0-tlast)

Analysis denominator · Participants

GroupSource count
Phase 2: Pemetrexed + Cisplatin + LY260361832
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 2: Pemetrexed + Cisplatin + LY26036183930058Not reportedNot reportedNot reported
AUC (0-∞)

Analysis denominator · Participants

GroupSource count
Phase 2: Pemetrexed + Cisplatin + LY260361831
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 2: Pemetrexed + Cisplatin + LY26036184110059Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        49
        value
        31400
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    AUC (0-24)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        58
        value
        39300
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    AUC (0-tlast)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        59
        value
        41100
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    AUC (0-∞)
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
AUC (0-24), AUC(0-tlast), and AUC(0-∞) values are reported for LY2603618. The number of pharmacokinetic observations (n) used in the analysis is presented.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    OG000
    title
    Phase 2: Pemetrexed + Cisplatin + LY2603618
param Type
GEOMETRIC_MEAN
population Description
Phase 2 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 - predose, immediately prior to the end of the LY2603618 infusion, and 2-6, 24-48, and 72-96 hours postdose
title
Phase 2: Pharmacokinetic: AUC (LY2603618)
type
SECONDARY
unit Of Measure
ng*h/mL

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

Preserved source evidence · Not medical advice