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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01403064
First Posted: July 27, 2011
Last Update Posted: June 25, 2014
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.
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
  Purpose
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

Condition Intervention Phase
Oral Mucositis Biological: ALD518 Drug: 0.9% saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alder Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label ALD518 Biological: ALD518
IV
Experimental: ALD518 Dose 1 Biological: ALD518
IV
Experimental: ALD518 Dose 2 Biological: ALD518
IV
Placebo Comparator: Placebo Drug: 0.9% saline
IV Infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403064


  Show 31 Study Locations
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
Study Director: Jeffrey Smith, MD FRCP Alder Biopharmaceuticals, Inc.
  More Information

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01403064     History of Changes
Other Study ID Numbers: ALD518-CLIN-009
First Submitted: July 25, 2011
First Posted: July 27, 2011
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Alder Biopharmaceuticals, Inc.:
Oral mucositis; head and neck cancer; chemotherapy; radiotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases