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NCT03201250 · OUTCOME

Maximum Tolerated Dose (MTD) of Daily Cabozantinib Given

Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple Myeloma · Source last updated 2023-09-08

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
1 cycle (approximately 28 days)

What was measured

The investigators will study three dose levels using the 3+3 algorithm. MTD will be assess with dose limiting toxicities (DLTs) based solely on adverse events that occur during cycle 1.

Analysis population: Only subjects that were dosed are included in this analysis

Groups in this outcome

Treatment

Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg or Level 0 = 40 mg or Level +1 = 60 mg, PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)

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

Analysis denominator · Participants

GroupSource count
Treatment8

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The investigators will study three dose levels using the 3+3 algorithm. MTD will be assess with dose limiting toxicities (DLTs) based solely on adverse events that occur during cycle 1.
groups
  1. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg or Level 0 = 40 mg or Level +1 = 60 mg, PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    OG000
    title
    Treatment
param Type
NUMBER
population Description
Only subjects that were dosed are included in this analysis
reporting Status
POSTED
time Frame
1 cycle (approximately 28 days)
title
Maximum Tolerated Dose (MTD) of Daily Cabozantinib Given
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice