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NCT01776723 · OUTCOME

Occurrence of Clinical Response

A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib · Source last updated 2022-09-22

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Phase II - Proportion of participants achieving clinical benefit defined as hematologic improvement, complete remission (CR), partial remission (PR), marrow complete remission (Marrow CR) or stable disease (SD) by the International Working Group (IWG) 2006 criteria. Erythroid Response for pretreatment hemoglobin \< 11 g/dl; Platelet response for subjects with a pre-treatment platelet count \< 50 x 10\^9/L; Neutrophil response with pretreatment absolute neutrophil count (ANC) \< 1 x 10\^9/L.

Analysis population: All participants who received ruxolitinib therapy

Groups in this outcome

II: Maximum Tolerated Dose - Ruxolitinib

Phase II: Treatment at Maximum Tolerated Dose (MTD). Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.

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

Analysis denominator · Participants

GroupSource count
II: Maximum Tolerated Dose - Ruxolitinib30

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
II: Maximum Tolerated Dose - Ruxolitinib18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Phase II - Proportion of participants achieving clinical benefit defined as hematologic improvement, complete remission (CR), partial remission (PR), marrow complete remission (Marrow CR) or stable disease (SD) by the International Working Group (IWG) 2006 criteria. Erythroid Response for pretreatment hemoglobin \< 11 g/dl; Platelet response for subjects with a pre-treatment platelet count \< 50 x 10\^9/L; Neutrophil response with pretreatment absolute neutrophil count (ANC) \< 1 x 10\^9/L.
groups
  1. description
    Phase II: Treatment at Maximum Tolerated Dose (MTD). Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
    id
    OG000
    title
    II: Maximum Tolerated Dose - Ruxolitinib
param Type
NUMBER
population Description
All participants who received ruxolitinib therapy
reporting Status
POSTED
time Frame
Up to 2 years
title
Occurrence of Clinical Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice