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NCT02300610 · OUTCOME

Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 6 months

What was measured

Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: All participants evaluable at time of analysis.

Groups in this outcome

Dose Escalation: Level 1 Dose

Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).

Dose Escalation: Level 2 Dose

Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).

Dose Expansion

Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.

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 Escalation: Level 1 Dose3
Dose Escalation: Level 2 Dose3
Dose Expansion4

Reported measurements

Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: Level 1 Dose0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Level 2 Dose3Not reportedNot reportedNot reportedNot reported
Dose Expansion1Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: Level 1 Dose1Not reportedNot reportedNot reportedNot reported
Dose Escalation: Level 2 Dose0Not reportedNot reportedNot reportedNot reported
Dose Expansion0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: Level 1 Dose1Not reportedNot reportedNot reportedNot reported
Dose Escalation: Level 2 Dose0Not reportedNot reportedNot reportedNot reported
Dose Expansion1Not reportedNot reportedNot reportedNot reported
Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: Level 1 Dose0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Level 2 Dose0Not reportedNot reportedNot reportedNot reported
Dose Expansion1Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: Level 1 Dose1Not reportedNot reportedNot reportedNot reported
Dose Escalation: Level 2 Dose0Not reportedNot reportedNot reportedNot reported
Dose Expansion1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Progressive Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Complete Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
groups
  1. description
    Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
    id
    OG000
    title
    Dose Escalation: Level 1 Dose
  2. description
    Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
    id
    OG001
    title
    Dose Escalation: Level 2 Dose
  3. description
    Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
    id
    OG002
    title
    Dose Expansion
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants evaluable at time of analysis.
reporting Status
POSTED
time Frame
Up to 6 months
title
Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice