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NCT02564198 · OUTCOME

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors · Source last updated 2021-08-17

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Date of Objective Disease Progression (Up to 42 Months)

What was measured

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Analysis population: All randomized participants who received at least one dose of study drug.

Groups in this outcome

8 mg/kg Ramucirumab (Part A)

Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.

12 mg/kg Ramucirumab (Part A)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

12 mg/kg Ramucirumab (Part B)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

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

Analysis denominator · Participants

GroupSource count
8 mg/kg Ramucirumab (Part A)8
12 mg/kg Ramucirumab (Part A)15
12 mg/kg Ramucirumab (Part B)6

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
8 mg/kg Ramucirumab (Part A)0Not reported0.041.0Not reported
12 mg/kg Ramucirumab (Part A)0Not reported0.023.2Not reported
12 mg/kg Ramucirumab (Part B)0Not reported0.045.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        41.0
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        23.2
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
    id
    OG000
    title
    8 mg/kg Ramucirumab (Part A)
  2. description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    OG001
    title
    12 mg/kg Ramucirumab (Part A)
  3. description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    OG002
    title
    12 mg/kg Ramucirumab (Part B)
param Type
NUMBER
population Description
All randomized participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Baseline to Date of Objective Disease Progression (Up to 42 Months)
title
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice