NCT01866293 · OUTCOME

Safety and Toxicity in This Patient Population

Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma · Source last updated 2017-08-30

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 1 year

What was measured

Safety assessments and toxicity grading will follow CTCAE Version 4 Grade

Groups in this outcome

Cabozantinib (XL184)

Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.

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
Cabozantinib (XL184)	11

Reported measurements

Source class 1

Evaluable

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cabozantinib (XL184)	9	Not reported	Not reported	Not reported	Not reported

Unevaluable - Enrolled but never started treatment

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cabozantinib (XL184)	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
9
title
Evaluable
measurements
group Id
OG000
value
2
title
Unevaluable - Enrolled but never started treatment

denoms

counts
group Id
OG000
value
11
units
Participants

description

Safety assessments and toxicity grading will follow CTCAE Version 4 Grade

groups

description
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
id
OG000
title
Cabozantinib (XL184)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

1 year

title

Safety and Toxicity in This Patient Population

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice