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NCT02047253 · OUTCOME

Number of Participants With Circulating Tumor Cell (CTC) Decline Over Three Time Points (Before Study Initiation, Day 1 of Cycles 2 and 4

Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment · Source last updated 2018-12-19

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
Baseline through 36 months

What was measured

The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by \>30%. Three collections: before study initiation, Day 1 of Cycles 2 and 4

Analysis population: 1 patient did not have blood draw. 27 patients had blood draws for CTC enumeration across baseline, Cycle 2 day 1 and cycle 4 day 1.

Groups in this outcome

Carfilzomib

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily

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

Analysis denominator · Participants

GroupSource count
Carfilzomib27

Reported measurements

Source class 1

CTC decline

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib3Not reportedNot reportedNot reportedNot reported

CTC increased or No change/decline in CTC levels

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      title
      CTC decline
    2. measurements
      1. group Id
        OG000
        value
        24
      title
      CTC increased or No change/decline in CTC levels
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by \>30%. Three collections: before study initiation, Day 1 of Cycles 2 and 4
groups
  1. description
    Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
    id
    OG000
    title
    Carfilzomib
param Type
COUNT_OF_PARTICIPANTS
population Description
1 patient did not have blood draw. 27 patients had blood draws for CTC enumeration across baseline, Cycle 2 day 1 and cycle 4 day 1.
reporting Status
POSTED
time Frame
Baseline through 36 months
title
Number of Participants With Circulating Tumor Cell (CTC) Decline Over Three Time Points (Before Study Initiation, Day 1 of Cycles 2 and 4
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice