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NCT02300610 · OUTCOME

Recommended Dose of Enzalutamide

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer · Source last updated 2019-08-01

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
Up to 6 months

What was measured

Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide. Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT. * 7 consecutive missed doses (out of 21 doses) of enzalutamide in 21 days due to study drug related toxicity. * Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT. * Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity. * Discontinuation of a patient due to study drug related toxicity before completing cycle 1.

Analysis population: All participants in Dose Escalation arm.

Groups in this outcome

Dose Escalation

Dose Escalation: Begin with Level 1 dose of enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).

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

Analysis denominator · Participants

GroupSource count
Dose Escalation6

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation160Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        160
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide. Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT. * 7 consecutive missed doses (out of 21 doses) of enzalutamide in 21 days due to study drug related toxicity. * Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT. * Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity. * Discontinuation of a patient due to study drug related toxicity before completing cycle 1.
groups
  1. description
    Dose Escalation: Begin with Level 1 dose of enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
    id
    OG000
    title
    Dose Escalation
param Type
NUMBER
population Description
All participants in Dose Escalation arm.
reporting Status
POSTED
time Frame
Up to 6 months
title
Recommended Dose of Enzalutamide
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice