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NCT00510068 · OUTCOME

Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors · Source last updated 2015-07-01

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010

What was measured

Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as "Non-elevated". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors.

Analysis population: The Full Analysis Set (FAS) consisted of all patients who were randomized.

Groups in this outcome

Everolimus 10 mg/Day

Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).

Placebo

Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).

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

Analysis denominator · Participants

GroupSource count
Everolimus 10 mg/Day207
Placebo203

Reported measurements

CgA Levels at baseline: CgA <= 2x ULN (n:121, 97)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day11.17Not reported8.5416.49Not reported
Placebo4.90Not reported2.995.55Not reported
CgA levels at baseline: CgA > 2x ULN (n:84, 103)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day8.54Not reported7.6913.80Not reported
Placebo4.34Not reported2.865.39Not reported
Early CgA response: Response (n: 48, 22)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day8.54Not reported7.5614.00Not reported
Placebo5.70Not reported3.198.54Not reported
Early CgA response: Non-Response (n:40, 82)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day11.14Not reported6.90NAUpper boundary of the 95% Confidence Interval (CI) was not be computable
Placebo3.19Not reported2.835.36Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.54
        upper Limit
        16.49
        value
        11.17
      2. group Id
        OG001
        lower Limit
        2.99
        upper Limit
        5.55
        value
        4.90
    title
    CgA Levels at baseline: CgA <= 2x ULN (n:121, 97)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.69
        upper Limit
        13.80
        value
        8.54
      2. group Id
        OG001
        lower Limit
        2.86
        upper Limit
        5.39
        value
        4.34
    title
    CgA levels at baseline: CgA > 2x ULN (n:84, 103)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.56
        upper Limit
        14.00
        value
        8.54
      2. group Id
        OG001
        lower Limit
        3.19
        upper Limit
        8.54
        value
        5.70
    title
    Early CgA response: Response (n: 48, 22)
  4. categories
    1. measurements
      1. comment
        Upper boundary of the 95% Confidence Interval (CI) was not be computable
        group Id
        OG000
        lower Limit
        6.90
        upper Limit
        NA
        value
        11.14
      2. group Id
        OG001
        lower Limit
        2.83
        upper Limit
        5.36
        value
        3.19
    title
    Early CgA response: Non-Response (n:40, 82)
denoms
  1. counts
    1. group Id
      OG000
      value
      207
    2. group Id
      OG001
      value
      203
    units
    Participants
description
Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as "Non-elevated". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
    id
    OG000
    title
    Everolimus 10 mg/Day
  2. description
    Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) consisted of all patients who were randomized.
reporting Status
POSTED
time Frame
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
title
Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice