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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01403064
First received: July 25, 2011
Last updated: March 7, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy endpoint of OM assessments [ Time Frame: Measured from onset of OM through Week 4 Post-RT ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • C-reactive protein serum concentrations [ Time Frame: Measured at intervals from Screening visit through Week 4 Post-RT ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: July 2011
Estimated Study Completion Date: April 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403064

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

No publications provided

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01403064     History of Changes
Other Study ID Numbers: ALD518-CLIN-009
Study First Received: July 25, 2011
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Austria: Ethikkommission
Austria: Agency for Health and Food Safety

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

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

ClinicalTrials.gov processed this record on April 17, 2014