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NCT03601897 · OUTCOME

PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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

Measure
GEOMETRIC_MEAN
Unit
Hour times nanograms per hour (h*ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)

What was measured

Measure the AUC 0-6 hours

Analysis population: Part 1 participants who received any study drug and had evaluable AUC data at each timepoint.

Groups in this outcome

Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2

Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

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

Analysis denominator · Participants

GroupSource count
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^224
Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^219

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^224
Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^219
Values in Hour times nanograms per hour (h*ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^220467.9Not reportedNot reportedNot reported
Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^233783.9Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^218
Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^215
Values in Hour times nanograms per hour (h*ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^228380.8Not reportedNot reportedNot reported
Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^245756.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.9
        value
        204
      2. group Id
        OG001
        spread
        83.9
        value
        337
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.8
        value
        283
      2. group Id
        OG001
        spread
        56.6
        value
        457
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        15
      units
      Participants
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Measure the AUC 0-6 hours
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
    id
    OG000
    title
    Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
  2. description
    Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
    id
    OG001
    title
    Part 1 Arm 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
param Type
GEOMETRIC_MEAN
population Description
Part 1 participants who received any study drug and had evaluable AUC data at each timepoint.
reporting Status
POSTED
time Frame
Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
title
PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
type
SECONDARY
unit Of Measure
Hour times nanograms per hour (h*ng/mL)

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

Preserved source evidence · Not medical advice