NCT00112723 · OUTCOME

Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2016-08-08

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

Measure: NUMBER
Unit: patients
Interval / dispersion: Not reported
Time frame: Up to 30 days after completion of study treatment

Groups in this outcome

All Dose Levels of Alvocidib

PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV

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
All Dose Levels of Alvocidib	35

Reported measurements

Source class 1

Values in patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Dose Levels of Alvocidib	8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
8

denoms

counts
group Id
OG000
value
35
units
Participants

groups

description
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
id
OG000
title
All Dose Levels of Alvocidib

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 30 days after completion of study treatment

title

Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)

type

SECONDARY

unit Of Measure

patients

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

Preserved source evidence · Not medical advice