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NCT01098266 · OUTCOME

Disease Control Rate (DCR)

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed · Source last updated 2019-09-17

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
Assessed every 6-12 weeks, up to 100 weeks

What was measured

Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Groups in this outcome

A: NGR-hTNF + BIC

NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)

B: Placebo+BIC

Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)

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

Analysis denominator · Participants

GroupSource count
A: NGR-hTNF + BIC200
B: Placebo+BIC200

Reported measurements

Disease control rate (DCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC114Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC109Not reportedNot reportedNot reportedNot reported
Complete or partial response (CR o PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC3Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC6Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC111Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC103Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC51Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC71Not reportedNot reportedNot reportedNot reported
Nonassessable (NA)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC35Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC20Not 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
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    estimate Comment
    Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner
    group Description
    Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.62
    param Type
    Odds Ratio (OR)
    param Value
    1.13
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    estimate Comment
    Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner
    group Description
    Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.62
    param Type
    Odds Ratio (OR)
    param Value
    1.13
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        114
      2. group Id
        OG001
        value
        109
    title
    Disease control rate (DCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
    title
    Complete or partial response (CR o PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        111
      2. group Id
        OG001
        value
        103
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        71
    title
    Progressive disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        20
    title
    Nonassessable (NA)
denoms
  1. counts
    1. group Id
      OG000
      value
      200
    2. group Id
      OG001
      value
      200
    units
    Participants
description
Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
groups
  1. description
    NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
    id
    OG000
    title
    A: NGR-hTNF + BIC
  2. description
    Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
    id
    OG001
    title
    B: Placebo+BIC
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Assessed every 6-12 weeks, up to 100 weeks
title
Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice