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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Oral Mucositis

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

Safety and tolerability of ALD518, including incidence of adverse events, serious adverse events and clinically significant laboratory abnormalities

Outcome Time Frame:

Participants will be followed for the duration of the trial, an expected average of 12 months

Safety Issue:

Yes

Principal Investigator

Jeffrey Smith, MD FRCP

Investigator Role:

Study Director

Investigator Affiliation:

Alder Biopharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ALD518-CLIN-009

NCT ID:

NCT01403064

Start Date:

July 2011

Completion Date:

April 2013

Related Keywords:

  • Oral Mucositis
  • Oral mucositis; head and neck cancer; chemotherapy; radiotherapy
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Morton Plant Mease Health CareClearwater, Florida  33756
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Temple University HospitalPhiladelphia, Pennsylvania  19140
SUNY Upstate Medical UniversitySyracuse, New York  13210
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Texas Southwestern Medical CenterDallas, Texas  
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Karmanos Cancer CenterDetroit, Michigan  48201
Detroit Clinical Research CenterFarmington Hills, Michigan  48336
Cancer Specialists of Southern TexasCorpus Christi, Texas  78412
VA Puget Sound Health Care SyatemSeattle, Washington  98108