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NCT01139775 · OUTCOME

Phase 1: Pharmacokinetic: AUC (Pemetrexed and Cisplatin)

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
Pemetrexed: Cycle 1/Day 1 - immediately prior to end of pemetrexed infusion and 1, 2, 6 and 24 hours postdose. Cisplatin: Cycle 1/Day 1 - immediately prior to end of cisplatin infusion and 0.5, 1, 2, 6, 24, 72, 96, and 168 hours postdose.

What was measured

AUC(0-tlast) and AUC(0-∞) values are reported for pemetrexed and t-platinum from cisplatin. The number of pharmacokinetic observations (n) used in the analysis is presented for each drug.

Analysis population: Phase 1 participants who received at least 1 dose of pemetrexed or cisplatin 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 + LY260361814

Reported measurements

Pemetrexed, AUC(0-tlast)
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY260361815900035Not reportedNot reportedNot reported
Pemetrexed, AUC (0-∞)
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY260361816000035Not reportedNot reportedNot reported
T-platinum from cisplatin, AUC (0-tlast)
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY260361816300026Not reportedNot reportedNot reported
T-platinum from cisplatin, AUC (0-∞)
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY260361826900026Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        35
        value
        159000
    title
    Pemetrexed, AUC(0-tlast)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35
        value
        160000
    title
    Pemetrexed, AUC (0-∞)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        26
        value
        163000
    title
    T-platinum from cisplatin, AUC (0-tlast)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        26
        value
        269000
    title
    T-platinum from cisplatin, AUC (0-∞)
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
AUC(0-tlast) and AUC(0-∞) values are reported for pemetrexed and t-platinum from cisplatin. The number of pharmacokinetic observations (n) used in the analysis is presented for each drug.
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 pemetrexed or cisplatin and had samples collected for pharmacokinetic analysis.
reporting Status
POSTED
time Frame
Pemetrexed: Cycle 1/Day 1 - immediately prior to end of pemetrexed infusion and 1, 2, 6 and 24 hours postdose. Cisplatin: Cycle 1/Day 1 - immediately prior to end of cisplatin infusion and 0.5, 1, 2, 6, 24, 72, 96, and 168 hours postdose.
title
Phase 1: Pharmacokinetic: AUC (Pemetrexed and Cisplatin)
type
SECONDARY
unit Of Measure
ng*h/mL

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

Preserved source evidence · Not medical advice