Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04111107 · OUTCOME

Response Rate

Precision Medicine for Patients With Identified Actionable Mutations · Source last updated 2024-07-03

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 30 days after treatment ends, up to 33 months

What was measured

Response rate will be estimated for all patients with corresponding 95% confidence intervals. Complete response is the disappearance of all target lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to less than 10 mm. Partial response is at least 30% decrease in the sum of diameters of target lesions. Progressive disease is greater than 20% increase and a minimum 5 mm increase over the nadir. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Analysis population: Eleven patients did not receive study treatment (due to patient withdrawal or declining health) and ten patients died prior to evaluation for response.

Groups in this outcome

Drug Administration Based on Next Gen Sequencing Report

Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.

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

Analysis denominator · Participants

GroupSource count
Drug Administration Based on Next Gen Sequencing Report24

Reported measurements

Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Drug Administration Based on Next Gen Sequencing Report1Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Drug Administration Based on Next Gen Sequencing Report10Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Drug Administration Based on Next Gen Sequencing Report13Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    21.1
    estimate Comment
    exact binomial confidence interval
    group Description
    The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated
    group Ids
    1. OG000
    non Inferiority Comment
    Single proportion was estimated.
    non Inferiority Type
    OTHER
    param Type
    proportion
    param Value
    4.2
Complete source fields
analyses
  1. ci Lower Limit
    0.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    21.1
    estimate Comment
    exact binomial confidence interval
    group Description
    The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated
    group Ids
    1. OG000
    non Inferiority Comment
    Single proportion was estimated.
    non Inferiority Type
    OTHER
    param Type
    proportion
    param Value
    4.2
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Stable Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Response rate will be estimated for all patients with corresponding 95% confidence intervals. Complete response is the disappearance of all target lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to less than 10 mm. Partial response is at least 30% decrease in the sum of diameters of target lesions. Progressive disease is greater than 20% increase and a minimum 5 mm increase over the nadir. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
groups
  1. description
    Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
    id
    OG000
    title
    Drug Administration Based on Next Gen Sequencing Report
param Type
COUNT_OF_PARTICIPANTS
population Description
Eleven patients did not receive study treatment (due to patient withdrawal or declining health) and ten patients died prior to evaluation for response.
reporting Status
POSTED
time Frame
Up to 30 days after treatment ends, up to 33 months
title
Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice