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NCT00412061 · OUTCOME

Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor · Source last updated 2014-11-21

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
If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

What was measured

Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".

Analysis population: The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.

Groups in this outcome

Octreotide+ Everolimus

Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

Octreotide+ Placebo

Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on 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
Octreotide+ Everolimus212
Octreotide+ Placebo208

Reported measurements

CgA<=2x ULN (n=60,78)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Octreotide+ Everolimus31.31Not reported19.32NAUpper Limit was not applicable or computable as median was just reached.
Octreotide+ Placebo20.07Not reported13.04NAUpper Limit was not applicable or computable as median was just reached.
CgA>2x ULN (n=152,130)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Octreotide+ Everolimus13.93Not reported11.3017.08Not reported
Octreotide+ Placebo8.41Not reported7.7211.14Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper Limit was not applicable or computable as median was just reached.
        group Id
        OG000
        lower Limit
        19.32
        upper Limit
        NA
        value
        31.31
      2. comment
        Upper Limit was not applicable or computable as median was just reached.
        group Id
        OG001
        lower Limit
        13.04
        upper Limit
        NA
        value
        20.07
    title
    CgA<=2x ULN (n=60,78)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.30
        upper Limit
        17.08
        value
        13.93
      2. group Id
        OG001
        lower Limit
        7.72
        upper Limit
        11.14
        value
        8.41
    title
    CgA>2x ULN (n=152,130)
denoms
  1. counts
    1. group Id
      OG000
      value
      212
    2. group Id
      OG001
      value
      208
    units
    Participants
description
Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".
dispersion Type
95% Confidence Interval
groups
  1. description
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    id
    OG000
    title
    Octreotide+ Everolimus
  2. description
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
    id
    OG001
    title
    Octreotide+ Placebo
param Type
MEDIAN
population Description
The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.
reporting Status
POSTED
time Frame
If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
title
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice