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

NCT01403064 | Terminated Phase 2 Results DMC

• 1 other identifier: ALD518-CLIN-009
• Study Type: interventional
• Target: 76
• Locations: 5 countries
• Sites: 25

Brief Summary

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

Conditions

Oral Mucositis

Keywords

Oral mucositis; head and neck cancer; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (4)

• Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities

  Up to 15 months

• Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities

  Up to 15 months

• Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy

  Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy

  Up to 12 weeks

• Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy

  The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy

  Up to 12 weeks

Secondary Outcomes (11)

• Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)

  Up to 12 weeks

• Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)

  Up to 12 weeks

• Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)

  Measured from onset of OM through Week 12

• Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)

  Up to 12 weeks

• Duration of Ulcerative and Severe OM

  Up to 12 weeks

Study Arms (4)

Open Label ALD518

EXPERIMENTAL

Biological: ALD518

ALD518 Dose 1

EXPERIMENTAL

Biological: ALD518

ALD518 Dose 2

EXPERIMENTAL

Biological: ALD518

Placebo

PLACEBO COMPARATOR

Drug: 0.9% saline

Interventions

ALD518 BIOLOGICAL

IV

ALD518 Dose 1; ALD518 Dose 2; Open Label ALD518

0.9% saline DRUG

IV Infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (31)

Morton Plant Mease Health Care

Clearwater, Florida, 33756, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Detroit Clinical Research Center

Farmington Hills, Michigan, 48336, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Cancer Specialists of Southern Texas

Corpus Christi, Texas, 78412, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

VA Puget Sound Health Care Syatem

Seattle, Washington, 98108, United States

Location

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Royale Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Adelaide Radiotherapy Centre

Adelaide, South Australia, 5037, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

LKH Graz, HNO Ambulanz

Graz, Austria

Location

Univ. Klinik fur Innere Medizin III

Salzburg, 5020, Austria

Location

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

Cancer Centre of Southeastern Ontario

Kingston, Ontario, K7L 5P9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

CHUQ-L'Hotel-Dieu de Quebec

Québec, G1R 2J6, Canada

Location

Uniklinik Koln

Cologne, 50924, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Medical School, Saarland

Homburg, 66424, Germany

Location

A.O. San Paolo - Polo Universitario

Milan, 20142, Italy

Location

Istituto Nazionale dei tumari

Milan, Italy

Location

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Interventions

clazakizumab; Saline Solution

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: CSL Behring

clinicaltrials@cslbehring.com

610-878-4000

Study Officials

• Jeffrey Smith, MD FRCP

  Alder Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

AU (3); IT (3); US (13); CA (3); DE (3)