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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01403064
Registration number
NCT01403064
Ethics application status
Date submitted
25/07/2011
Date registered
27/07/2011
Date last updated
11/05/2021
Titles & IDs
Public title
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
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Scientific title
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALD518 in the Reduction of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concomitant Chemotherapy and Radiotherapy
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Secondary ID [1]
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ALD518-CLIN-009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Oral Mucositis
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Condition category
Condition code
Cancer
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Head and neck
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - ALD518
Treatment: Drugs - 0.9% saline
Experimental: Open Label ALD518 -
Experimental: ALD518 Dose 1 -
Experimental: ALD518 Dose 2 -
Placebo Comparator: Placebo -
Other interventions: ALD518
IV
Treatment: Drugs: 0.9% saline
IV Infusion
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
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Assessment method [1]
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Timepoint [1]
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Up to 15 months
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Primary outcome [2]
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Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
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Assessment method [2]
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Timepoint [2]
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Up to 15 months
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Primary outcome [3]
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Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy
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Assessment method [3]
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Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being = 55 Gy
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Timepoint [3]
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Up to 12 weeks
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Primary outcome [4]
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Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
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Assessment method [4]
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The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being = 55 Gy
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Timepoint [4]
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Up to 12 weeks
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Secondary outcome [1]
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Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
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Assessment method [1]
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The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being =35 Gy, =45 Gy, =55 Gy or= 65 Gy
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Timepoint [1]
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Up to 12 weeks
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Secondary outcome [2]
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Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
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Assessment method [2]
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The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being =35 Gy, =45 Gy, =55 Gy or= 65 Gy
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Timepoint [2]
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Up to 12 weeks
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Secondary outcome [3]
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Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
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Assessment method [3]
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The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being =35 Gy, =45 Gy, =55 Gy or= 65 Gy
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Timepoint [3]
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Measured from onset of OM through Week 12
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Secondary outcome [4]
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Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
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Assessment method [4]
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The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being =35 Gy, =45 Gy, =55 Gy or= 65 Gy
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Timepoint [4]
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Up to 12 weeks
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Secondary outcome [5]
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Duration of Ulcerative and Severe OM
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Assessment method [5]
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Timepoint [5]
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Up to 12 weeks
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Secondary outcome [6]
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Time to Onset of Ulcerative and Severe OM
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Assessment method [6]
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Timepoint [6]
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Up to 12 weeks
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Secondary outcome [7]
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ALD518 Plasma Concentration at Varying Weeks
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Assessment method [7]
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Timepoint [7]
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Baseline and up to 12 weeks
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Secondary outcome [8]
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Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
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Assessment method [8]
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Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health.
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Timepoint [8]
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Baseline and up to 12 weeks
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Secondary outcome [9]
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Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
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Assessment method [9]
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The FACT-HN consists of 28 general + 11 head and neck specific items, each rated on a 0 (not at all) to 4 (very much) Likert type scale. The total score ranges from 0 to 148. Higher scores represent better quality of life.
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Timepoint [9]
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Baseline and up to 12 weeks
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Secondary outcome [10]
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Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
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Assessment method [10]
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The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale from 0 (not at all fatigued) to 4 (very much fatigued). The total score ranges from 0 to 52. Higher scores represent less fatigue.
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Timepoint [10]
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Baseline and up to 12 weeks
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Secondary outcome [11]
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Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
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Assessment method [11]
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The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body.
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Timepoint [11]
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Baseline and up to 12 weeks
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Eligibility
Key inclusion criteria
- Have recently diagnosed (< than 6 months prior to screening visit date),
pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx,
hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects
with a history of surgical management (approximately 4-6 weeks before RT with
sufficient time for post-surgical healing) are eligible
- Have a plan to receive a continuous course of conventional external beam irradiation
delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0
to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.
- Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to
100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin
regimen administered weekly (100 mg/m2)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status = 1
- CRP < 80 mg/L
- Have adequate hematopoietic, hepatic, and renal function at the screening visit
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor
- Metastatic disease (M1) Stage IV C
- Any prior history of head and neck cancer
- Prior radiation to the head and neck
- Have had a major surgical procedure, other than for HNC, or significant traumatic
injury within 4 weeks prior to the initiation of RT; or anticipation of need for a
major surgical procedure during the clinical trial
- Active infectious disease, excluding oral candidiasis
- Have OM at the screening visit
- Have a history of hypersensitivity to monoclonal antibody
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2014
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Sample size
Target
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [3]
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Royale Brisbane and Women's Hospital - Herston
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Recruitment hospital [4]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [5]
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Adelaide Radiotherapy Centre - Adelaide
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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- Woolloongabba
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Recruitment postcode(s) [5]
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5037 - Adelaide
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Recruitment postcode(s) [6]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Michigan
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Country [4]
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United States of America
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State/province [4]
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New Jersey
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Country [5]
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United States of America
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State/province [5]
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New Mexico
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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Pennsylvania
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Country [8]
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United States of America
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State/province [8]
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South Carolina
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Country [9]
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United States of America
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State/province [9]
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Texas
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Country [10]
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United States of America
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State/province [10]
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Washington
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Country [11]
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Austria
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State/province [11]
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Graz
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Country [12]
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Austria
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State/province [12]
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Salzburg
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Country [13]
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Austria
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State/province [13]
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Vienna
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Country [14]
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Canada
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State/province [14]
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Ontario
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Country [15]
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Canada
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State/province [15]
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Quebec
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Country [16]
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Germany
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State/province [16]
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Freiburg
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Country [17]
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Germany
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State/province [17]
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Homburg
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Country [18]
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Germany
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State/province [18]
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Koln
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Country [19]
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Italy
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State/province [19]
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Milan
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Country [20]
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Italy
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State/province [20]
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Udine
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the
course of oral mucositis in subjects with head and neck cancer receiving concomitant
chemotherapy and radiotherapy
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01403064
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jeffrey Smith, MD FRCP
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Address
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Alder Biopharmaceuticals, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01403064
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