NCT02546986 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
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

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

Group	Source count
CC-486 and Pembrolizumab (CC-486 + PBZ)	15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
CC-486 and Pembrolizumab (CC-486 + PBZ)	15

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
CC-486 and Pembrolizumab (CC-486 + PBZ)	94.7	69.49	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
CC-486 and Pembrolizumab (CC-486 + PBZ)	14

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
CC-486 and Pembrolizumab (CC-486 + PBZ)	110.0	73.46	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
69.49
value
94.7
denoms
counts
group Id
OG000
value
15
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
73.46
value
110.0
denoms
counts
group Id
OG000
value
14
units
Participants
title
Cycle 2 Day 1

denoms

counts
group Id
OG000
value
15
units
Participants

description

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

dispersion Type

Geometric Coefficient of Variation

groups

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

GEOMETRIC_MEAN

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

Maximum Observed Plasma Concentration (Cmax) of CC-486

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice