Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00819169 · OUTCOME

Time to Response

QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors · Source last updated 2024-08-20

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Time from first dose up to 24 months

What was measured

Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analyses of time to response was not calculated.

Groups in this outcome

Part 1 Cohort 1

AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Part 1 Cohort 2

AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Part 1 Cohort 3

AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Part 2 Cohort 1

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC

Part 2 Cohort 2

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC

Part 2 Cohort 3

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC

Part 2 Cohort 4

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer

Part 2 Cohort 5

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer

Part 2 Cohort 6

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma

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

Analysis denominator · Participants

GroupSource count
Part 1 Cohort 10
Part 1 Cohort 20
Part 1 Cohort 30
Part 2 Cohort 10
Part 2 Cohort 20
Part 2 Cohort 30
Part 2 Cohort 40
Part 2 Cohort 50
Part 2 Cohort 60

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    units
    Participants
description
Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
groups
  1. description
    AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    OG000
    title
    Part 1 Cohort 1
  2. description
    AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    OG001
    title
    Part 1 Cohort 2
  3. description
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    OG002
    title
    Part 1 Cohort 3
  4. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
    id
    OG003
    title
    Part 2 Cohort 1
  5. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
    id
    OG004
    title
    Part 2 Cohort 2
  6. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
    id
    OG005
    title
    Part 2 Cohort 3
  7. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
    id
    OG006
    title
    Part 2 Cohort 4
  8. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
    id
    OG007
    title
    Part 2 Cohort 5
  9. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
    id
    OG008
    title
    Part 2 Cohort 6
population Description
Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analyses of time to response was not calculated.
reporting Status
POSTED
time Frame
Time from first dose up to 24 months
title
Time to Response
type
SECONDARY

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

Preserved source evidence · Not medical advice