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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
ALD518-CLIN-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Mucositis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Timepoint [1] 0 0
Up to 15 months
Primary outcome [2] 0 0
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Timepoint [2] 0 0
Up to 15 months
Primary outcome [3] 0 0
Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy - 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
Timepoint [3] 0 0
Up to 12 weeks
Primary outcome [4] 0 0
Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy - 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
Timepoint [4] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) - 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
Timepoint [1] 0 0
Up to 12 weeks
Secondary outcome [2] 0 0
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) - 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
Timepoint [2] 0 0
Up to 12 weeks
Secondary outcome [3] 0 0
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) - 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
Timepoint [3] 0 0
Measured from onset of OM through Week 12
Secondary outcome [4] 0 0
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) - 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
Timepoint [4] 0 0
Up to 12 weeks
Secondary outcome [5] 0 0
Duration of Ulcerative and Severe OM
Timepoint [5] 0 0
Up to 12 weeks
Secondary outcome [6] 0 0
Time to Onset of Ulcerative and Severe OM
Timepoint [6] 0 0
Up to 12 weeks
Secondary outcome [7] 0 0
ALD518 Plasma Concentration at Varying Weeks
Timepoint [7] 0 0
Baseline and up to 12 weeks
Secondary outcome [8] 0 0
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) - Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health.
Timepoint [8] 0 0
Baseline and up to 12 weeks
Secondary outcome [9] 0 0
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) - 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.
Timepoint [9] 0 0
Baseline and up to 12 weeks
Secondary outcome [10] 0 0
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) - 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.
Timepoint [10] 0 0
Baseline and up to 12 weeks
Secondary outcome [11] 0 0
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks - The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body.
Timepoint [11] 0 0
Baseline and up to 12 weeks

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Royale Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Adelaide Radiotherapy Centre - Adelaide
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment postcode(s) [5] 0 0
5037 - Adelaide
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Salzburg
Country [13] 0 0
Austria
State/province [13] 0 0
Vienna
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Homburg
Country [18] 0 0
Germany
State/province [18] 0 0
Koln
Country [19] 0 0
Italy
State/province [19] 0 0
Milan
Country [20] 0 0
Italy
State/province [20] 0 0
Udine

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT01403064
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey Smith, MD FRCP
Address 0 0
Alder Biopharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01403064