Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403064
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

July 25, 2011
July 27, 2011
June 25, 2014
July 2011
April 2013   (Final data collection date for primary outcome measure)
  • Safety and tolerability of ALD518, including incidence of adverse events, serious adverse events and clinically significant laboratory abnormalities [ Time Frame: Participants will be followed for the duration of the trial, an expected average of 12 months ]
  • Clinically assessed ulcerative OM (Who Grade ≥ 2) at a cumulative radiation dose of 55 Gy [ Time Frame: The average time of this assessment will be 5-7 weeks after the initiation of RT ]
Same as current
Complete list of historical versions of study NCT01403064 on Archive Site
  • Secondary efficacy endpoint of OM assessments [ Time Frame: Measured from onset of OM through Week 4 Post-RT ]
    Ulcerative (WHO Grade ≥ 2) and severe (WHO Grade ≥ 3) OM at cumulative doses of 35 Gy, 45 Gy, 55 Gy and 65 Gy; Duration of ulcerative and severe OM, Time of onset of ulcerative and severe OM
  • Pharmacokinetics of ALD518 in plasma [ Time Frame: Measured at Baseline, Week 2, Week 4, Last Day of RT and Week 4 Post-RT ]
  • Impact of ALD518 on Patient-reported Outcomes as measured by the OMDQ, FACT-HN, and FACIT-fatigue scale [ Time Frame: Begins at baseline and is measured at least weekly though WEek 4 Post-RT ]
  • C-reactive protein serum concentrations [ Time Frame: Measured at intervals from Screening visit through Week 4 Post-RT ]
Same as current
Not Provided
Not Provided
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
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
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Oral Mucositis
  • Biological: ALD518
  • Drug: 0.9% saline
    IV Infusion
  • Experimental: Open Label ALD518
    Intervention: Biological: ALD518
  • Experimental: ALD518 Dose 1
    Intervention: Biological: ALD518
  • Experimental: ALD518 Dose 2
    Intervention: Biological: ALD518
  • Placebo Comparator: Placebo
    Intervention: Drug: 0.9% saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
April 2013   (Final data collection date for primary outcome measure)

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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   Germany,   Italy,   United States
Not Provided
Not Provided
Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc.
Not Provided
Study Director: Jeffrey Smith, MD FRCP Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP