Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects - Full Text View

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:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

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 May 16, 2013