Oral MucositisPhase 2NCT01403064
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
A Phase 2 study testing ALD518 and 0.9% saline in people with Oral Mucositis, run by CSL Behring at 31 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- ALD518 and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 31 sitesin 6 countries
- Study dates
- Jul 2011to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States13 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Morton Plant Mease Health Care
Clearwater, Florida, 33756
Cancer Specialists of Southern Texas
Corpus Christi, Texas, 78412
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Karmanos Cancer Center
Detroit, Michigan, 48201
Detroit Clinical Research Center
Farmington Hills, Michigan, 48336
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mount Sinai School of Medicine
New York, New York, 10029
Temple University Hospital
Philadelphia, Pennsylvania, 19140
VA Puget Sound Health Care Syatem
Seattle, Washington, 98108
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
SUNY Upstate Medical University
Syracuse, New York, 13210
Australia6 sites
Adelaide Radiotherapy Centre
Adelaide, South Australia, 5037
Royal Adelaide Hospital
Adelaide, South Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
Royale Brisbane and Women's Hospital
Herston, Queensland, 4029
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Princess Alexandra Hospital
Woolloongabba, Queensland
Austria3 sites
LKH Graz, HNO Ambulanz
Graz
Univ. Klinik fur Innere Medizin III
Salzburg, 5020
Hanusch Krankenhaus
Vienna, 1140
Canada3 sites
Cancer Centre of Southeastern Ontario
Kingston, Ontario, K7L 5P9
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
CHUQ-L'Hotel-Dieu de Quebec
Québec, G1R 2J6
Germany3 sites
Uniklinik Koln
Cologne, 50924
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
University Medical School, Saarland
Homburg, 66424
Italy3 sites
A.O. San Paolo - Polo Universitario
Milan, 20142
Istituto Nazionale dei tumari
Milan
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, 33100
About this study
Official 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
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
Read the detailed description
This was a Phase 2, placebo-controlled, double-blind study in subjects newly diagnosed with head and neck cancer (who had not received previous treatment for oral mucositis) and who were receiving concomitant chemotherapy and radiotherapy. Subject eligibility, including tumor staging, was assessed during the screening period, which was to occur within 30 days prior to the initiation of radiation therapy. The radiation therapy treatment period was approximately 7 weeks, depending on the subject's prescribed radiation plan. Prior to the randomized portion of the trial, the first 7 subjects enrolled in the study entered a safety run-in evaluation and received a total of 2 doses of open-label clazakizumab 160 mg IV, 4 weeks apart (Day 0 and Week 4 of radiation); these subjects were not eligible for the randomized portion of the study. Subsequent to completion of the safety run-in, eligible subjects were randomized 1:1:1 to treatment with 2 doses of clazakizumab 160 mg, or clazakizumab 320 mg, or placebo, administered IV 3 weeks apart (Day 0 and Week 3 of radiation therapy). All subjects were to be followed for 4 weeks post last day of radiotherapy treatment for the primary efficacy and safety assessments and then for up to an additional 12 months of long-term follow-up.
- Conditions
- Oral Mucositis
- Being tested
- ALD518, 0.9% saline
- Keywords
- Oral mucositis; head and neck cancer; chemotherapy; radiotherapy
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALD518Biological
IV
0.9% salineDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Open Label ALD518 | Experimental | Not described Receives: Biological: ALD518 |
| ALD518 Dose 1 | Experimental | Not described Receives: Biological: ALD518 |
| ALD518 Dose 2 | Experimental | Not described Receives: Biological: ALD518 |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Measured: Up to 15 months
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Measured: Up to 15 months
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
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
Secondary outcomes (11)
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
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
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
Measured: Measured from onset of OM through Week 12
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
Measured: Up to 12 weeks
Duration of Ulcerative and Severe OM
Measured: Up to 12 weeks
Time to Onset of Ulcerative and Severe OM
Measured: Up to 12 weeks
ALD518 Plasma Concentration at Varying Weeks
Measured: Baseline and up to 12 weeks
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.
Measured: Baseline and up to 12 weeks
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.
Measured: Baseline and up to 12 weeks
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.
Measured: Baseline and up to 12 weeks
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.
Measured: Baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionMar 2014
Why it stopped: due to lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Smith, MD FRCP, Study director, Alder Biopharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403064
- Sponsor's protocol ID
- ALD518-CLIN-009
- Status last verified
- Apr 2021
- First submitted
- 25 Jul 2011
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01403064
- Acronym / sponsor ID
- ALD518-CLIN-009
- Conditions
- Oral Mucositis
- Keywords
- Oral mucositis; head and neck cancer; chemotherapy; radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack of efficacy
- Enrolment
- 76 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This was a Phase 2, placebo-controlled, double-blind study in subjects newly diagnosed with head and neck cancer (who had not received previous treatment for oral mucositis) and who were receiving concomitant chemotherapy and radiotherapy. Subject eligibility, including tumor staging, was assessed during the screening period, which was to occur within 30 days prior to the initiation of radiation therapy. The radiation therapy treatment period was approximately 7 weeks, depending on the subject's prescribed radiation plan. Prior to the randomized portion of the trial, the first 7 subjects enrolled in the study entered a safety run-in evaluation and received a total of 2 doses of open-label clazakizumab 160 mg IV, 4 weeks apart (Day 0 and Week 4 of radiation); these subjects were not eligible for the randomized portion of the study. Subsequent to completion of the safety run-in, eligible subjects were randomized 1:1:1 to treatment with 2 doses of clazakizumab 160 mg, or clazakizumab 320 mg, or placebo, administered IV 3 weeks apart (Day 0 and Week 3 of radiation therapy). All subjects were to be followed for 4 weeks post last day of radiotherapy treatment for the primary efficacy and safety assessments and then for up to an additional 12 months of long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open Label ALD518 | Experimental | Biological: ALD518 |
| ALD518 Dose 1 | Experimental | Biological: ALD518 |
| ALD518 Dose 2 | Experimental | Biological: ALD518 |
| Placebo | Placebo comparator | Drug: 0.9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALD518IV | Biological | ALD518 Dose 1, ALD518 Dose 2, Open Label ALD518 |
| 0.9% salineIV Infusion | Drug | Placebo |
Primary outcome
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Time frame: Up to 15 months
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Time frame: Up to 15 months
Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy
Time frame: Up to 12 weeks
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
Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
Time frame: Up to 12 weeks
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
11 secondary outcomes
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
Time frame: Up to 12 weeks
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
Time frame: Up to 12 weeks
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
Time frame: Measured from onset of OM through Week 12
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
Time frame: Up to 12 weeks
Duration of Ulcerative and Severe OM
Time frame: Up to 12 weeks
Time to Onset of Ulcerative and Severe OM
Time frame: Up to 12 weeks
ALD518 Plasma Concentration at Varying Weeks
Time frame: Baseline and up to 12 weeks
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
Time frame: Baseline and up to 12 weeks
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
Time frame: Baseline and up to 12 weeks
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
Time frame: Baseline and up to 12 weeks
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Time frame: Baseline and up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Smith, MD FRCP study director
Alder Biopharmaceuticals, Inc.
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALD518 and 0.9% saline in people with Oral Mucositis, run by CSL Behring at 31 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Australia, Austria, Canada, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities (time frame: Up to 15 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.