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NCT02546986 · OUTCOME

Time to Maximum Plasma Concentration (Tmax) of CC-486

Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-07-22

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1

What was measured

Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.

Analysis population: The PK population includes participants with evaluable CC-486 plasma PK profile.

Groups in this outcome

CC-486 and Pembrolizumab (CC-486 + PBZ)

Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.

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

Analysis denominator · Participants

GroupSource count
CC-486 and Pembrolizumab (CC-486 + PBZ)15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
CC-486 and Pembrolizumab (CC-486 + PBZ)15
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CC-486 and Pembrolizumab (CC-486 + PBZ)1.5Not reported0.53.0Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
CC-486 and Pembrolizumab (CC-486 + PBZ)14
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CC-486 and Pembrolizumab (CC-486 + PBZ)1.5Not reported0.53.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        3.0
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        3.5
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.
dispersion Type
Full Range
groups
  1. description
    Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    OG000
    title
    CC-486 and Pembrolizumab (CC-486 + PBZ)
param Type
MEDIAN
population Description
The PK population includes participants with evaluable CC-486 plasma PK profile.
reporting Status
POSTED
time Frame
PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1
title
Time to Maximum Plasma Concentration (Tmax) of CC-486
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice