LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

January 19, 2018 updated by: Boehringer Ingelheim

A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
483

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Bs As, Argentina
        • 1200.43.05401 Boehringer Ingelheim Investigational Site
      • Santa Fe, Argentina
        • 1200.43.05402 Boehringer Ingelheim Investigational Site
      • Villa Dominico, Argentina
        • 1200.43.05403 Boehringer Ingelheim Investigational Site
  • Austria
      • Leoben, Austria
        • 1200.43.04303 Boehringer Ingelheim Investigational Site
      • Salzburg, Austria
        • 1200.43.04305 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1200.43.04301 Boehringer Ingelheim Investigational Site
  • Belgium
      • Bruxelles, Belgium
        • 1200.43.03202 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 1200.43.03203 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1200.43.03204 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1200.43.03201 Boehringer Ingelheim Investigational Site
  • Brazil
      • Barretos, Brazil
        • 1200.43.05504 Boehringer Ingelheim Investigational Site
      • Jau, Brazil
        • 1200.43.05505 Boehringer Ingelheim Investigational Site
      • Passo Fundo, Brazil
        • 1200.43.05507 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 1200.43.05503 Boehringer Ingelheim Investigational Site
      • Rio de Janeiro, Brazil
        • 1200.43.05502 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1200.43.05501 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1200.43.05506 Boehringer Ingelheim Investigational Site
  • Czechia
      • Olomouc, Czechia
        • 1200.43.04202 Boehringer Ingelheim Investigational Site
      • Prague 2, Czechia
        • 1200.43.04203 Boehringer Ingelheim Investigational Site
      • Prague 8, Czechia
        • 1200.43.04201 Boehringer Ingelheim Investigational Site
  • Denmark
      • København Ø, Denmark
        • 1200.43.04501 Boehringer Ingelheim Investigational Site
  • France
      • Avignon Cedex 9, France
        • 1200.43.03304 Boehringer Ingelheim Investigational Site
      • Clermont-Ferrand cedex 1, France, 63011
        • 1200.43.03306 Boehringer Ingelheim Investigational Site
      • Dijon Cedex, France
        • 1200.43.03312 Boehringer Ingelheim Investigational Site
      • Lille Cedex, France
        • 1200.43.03303 Boehringer Ingelheim Investigational Site
      • Lyon Cedex, France
        • 1200.43.03301 Boehringer Ingelheim Investigational Site
      • Montpellier cedex 5, France
        • 1200.43.03302 Boehringer Ingelheim Investigational Site
      • Nice cedex 2, France
        • 1200.43.03307 Boehringer Ingelheim Investigational Site
      • Paris Cedex 05, France
        • 1200.43.03314 Boehringer Ingelheim Investigational Site
      • Poitiers, France
        • 1200.43.03305 Boehringer Ingelheim Investigational Site
      • Rouen Cedex 1, France
        • 1200.43.03316 Boehringer Ingelheim Investigational Site
      • Saint Herblain Cedex, France
        • 1200.43.03309 Boehringer Ingelheim Investigational Site
      • Vandoeuvre les Nancy cedex, France
        • 1200.43.03310 Boehringer Ingelheim Investigational Site
      • Villejuif Cedex, France
        • 1200.43.03317 Boehringer Ingelheim Investigational Site
  • Germany
      • Aachen, Germany
        • 1200.43.04903 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1200.43.04902 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1200.43.04909 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1200.43.04901 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1200.43.04905 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1200.43.04906 Boehringer Ingelheim Investigational Site
      • Jena, Germany
        • 1200.43.04908 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1200.43.04904 Boehringer Ingelheim Investigational Site
      • Mannheim, Germany
        • 1200.43.04907 Boehringer Ingelheim Investigational Site
  • Greece
      • Haidari, Greece
        • 1200.43.03004 Boehringer Ingelheim Investigational Site
      • Heraklion, Greece
        • 1200.43.03005 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 1200.43.03002 Boehringer Ingelheim Investigational Site
  • Israel
      • Haifa, Israel
        • 1200.43.97201 Boehringer Ingelheim Investigational Site
      • Petach Tikva, Israel
        • 1200.43.97203 Boehringer Ingelheim Investigational Site
      • Tel Hashomer, Israel
        • 1200.43.97204 Boehringer Ingelheim Investigational Site
  • Italy
      • Aosta, Italy
        • 1200.43.03909 Boehringer Ingelheim Investigational Site
      • Cagliari, Italy
        • 1200.43.03908 Boehringer Ingelheim Investigational Site
      • Confreria (CN), Italy
        • 1200.43.03901 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1200.43.03907 Boehringer Ingelheim Investigational Site
      • Napoli, Italy
        • 1200.43.03903 Boehringer Ingelheim Investigational Site
      • Palermo, Italy
        • 1200.43.03905 Boehringer Ingelheim Investigational Site
      • Savona, Italy
        • 1200.43.03902 Boehringer Ingelheim Investigational Site
      • Taormina (ME), Italy
        • 1200.43.03904 Boehringer Ingelheim Investigational Site
      • Venezia, Italy
        • 1200.43.03906 Boehringer Ingelheim Investigational Site
      • Viterbo, Italy
        • 1200.43.03910 Boehringer Ingelheim Investigational Site
  • Japan
      • Aichi, Nagoya, Japan
        • 1200.43.08106 Boehringer Ingelheim Investigational Site
      • Chiba, Kashiwa, Japan
        • 1200.43.08103 Boehringer Ingelheim Investigational Site
      • Ehime, Matsuyama, Japan
        • 1200.43.08108 Boehringer Ingelheim Investigational Site
      • Hyogo, Akashi, Japan
        • 1200.43.08111 Boehringer Ingelheim Investigational Site
      • Hyogo, Kobe, Japan
        • 1200.43.08107 Boehringer Ingelheim Investigational Site
      • Kanagawa, Isehara, Japan
        • 1200.43.08109 Boehringer Ingelheim Investigational Site
      • Miyagi, Natori, Japan
        • 1200.43.08114 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1200.43.08110 Boehringer Ingelheim Investigational Site
      • Shizuoka, Sunto-gun, Japan
        • 1200.43.08105 Boehringer Ingelheim Investigational Site
      • Tochigi, Shimotsuke, Japan
        • 1200.43.08102 Boehringer Ingelheim Investigational Site
      • Tokyo, Koto-ku, Japan
        • 1200.43.08113 Boehringer Ingelheim Investigational Site
      • Tokyo, Meguro-ku, Japan
        • 1200.43.08104 Boehringer Ingelheim Investigational Site
      • Tokyo, Minato-ku, Japan
        • 1200.43.08112 Boehringer Ingelheim Investigational Site
  • Mexico
      • Mexico, Mexico
        • 1200.43.05202 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Ivanovo, Russian Federation
        • 1200.43.00704 Boehringer Ingelheim Investigational Site
      • Kurski, Russian Federation
        • 1200.43.00706 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1200.43.00709 Boehringer Ingelheim Investigational Site
      • Omsk, Russian Federation
        • 1200.43.00703 Boehringer Ingelheim Investigational Site
      • Pyatigorsk, Russian Federation
        • 1200.43.00710 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1200.43.00707 Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • 1200.43.00705 Boehringer Ingelheim Investigational Site
  • South Africa
      • Cape Town, South Africa
        • 1200.43.02703 Boehringer Ingelheim Investigational Site
      • Kraaifontein, Cape Town, South Africa
        • 1200.43.02704 Boehringer Ingelheim Investigational Site
      • Parktown, Johannesburg, South Africa
        • 1200.43.02701 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1200.43.02702 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1200.43.03401 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1200.43.03404 Boehringer Ingelheim Investigational Site
      • Girona, Spain
        • 1200.43.03405 Boehringer Ingelheim Investigational Site
      • Málaga, Spain
        • 1200.43.03406 Boehringer Ingelheim Investigational Site
      • Salamanca, Spain
        • 1200.43.03402 Boehringer Ingelheim Investigational Site
      • Zaragoza, Spain
        • 1200.43.03403 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1200.43.04602 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • 1200.43.04101 Boehringer Ingelheim Investigational Site
      • Bern, Switzerland
        • 1200.43.04102 Boehringer Ingelheim Investigational Site
  • United States
    • Illinois
      • Harvey, Illinois, United States
        • 1200.43.00113 Boehringer Ingelheim Investigational Site
      • Peoria, Illinois, United States
        • 1200.43.00106 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 1200.43.00110 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1200.43.00107 Boehringer Ingelheim Investigational Site
    • New York
      • Stony Brook, New York, United States
        • 1200.43.00105 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1200.43.00102 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 1200.43.00103 Boehringer Ingelheim Investigational Site
    • Texas
      • San Antonio, Texas, United States
        • 1200.43.00109 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
  2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
  3. Measurable disease according to RECIST
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
  2. Any other than one previous platinum based systemic regimen given for R/M disease
  3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
  4. Pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Afatinib (BIBW 2992)
Once daily
Drug: Afatinib
Once daily
Active Comparator: Methotrexate
Weekly
Drug: Methotrexate
Weekly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) Based on Central Independent Review
Time Frame: From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months

PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016).

The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied:

  • At least 20% increase in the Sum of Diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
  • Appearance of one or more new lesions
  • Unequivocal progression of existing non-target lesions
From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death or study completion date (06Dec2016); Up to 60 months
Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the study completion date (06 December 2016) were to be censored on the date that they were last known to be alive.
From randomization until death or study completion date (06Dec2016); Up to 60 months
Objective Response (OR)
Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months

OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis).

PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

Other factors which add to the overall response of an imaging timepoint as PR are as below:-

  • CR in TL, but non-CR/Non-Progressive Disease (PD) in NTL leads to PR
  • CR in TL, but not evaluated NTL leads to PR
  • PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;

All the above scenarios should also satisfy 'No occurrence of new lesions'.
Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months
Disease Control (DC)
Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months

DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD.

CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis).

PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

Other factors which add to the overall response of an imaging timepoint as PR are as below:-

  • CR in TL, but non-CR/Non-PD in NTL leads to PR
  • CR in TL, but not evaluated NTL leads to PR
  • PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;

SD for TL: change in the sum of diameters does not satisfy PR or PD.

SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.
Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months
Tumour Shrinkage
Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months

Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis.

Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase.

Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 - <20% increase, >0 - <30% decrease, >=30 - <50% decrease, >=50% decrease) are presented.
Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months
Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.

The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:

Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.

Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.

The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.

Changes in scores over time were assessed using longitudinal models.

The analyses of HRQOL are presented for the 07 May 2014 cut-off date.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.

The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:

Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.

Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.

The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.

Changes in scores over time were assessed using longitudinal models.

The analyses of HRQOL are presented for the 07 May 2014 cut-off date.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.

The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:

Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.

Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.

The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.

Changes in scores over time were assessed using longitudinal models.

The analyses of HRQOL are presented for the 07 May 2014 cut-off date.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Status Change in Pain Scale
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Status Change in Swallowing Scale
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Status Change in Global Health Status Scale
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Time to Deterioration in Pain
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Time to Deterioration in Swallowing
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Time to Deterioration in Global Health Status
Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1200.43
  • 2011-000391-34 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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