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

NCT ID: NCT01403064

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-03-31

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

Detailed Description

This was a Phase 2, placebo-controlled, double-blind study in subjects newly diagnosed with head and neck cancer (who had not received previous treatment for oral mucositis) and who were receiving concomitant chemotherapy and radiotherapy. Subject eligibility, including tumor staging, was assessed during the screening period, which was to occur within 30 days prior to the initiation of radiation therapy. The radiation therapy treatment period was approximately 7 weeks, depending on the subject's prescribed radiation plan. Prior to the randomized portion of the trial, the first 7 subjects enrolled in the study entered a safety run-in evaluation and received a total of 2 doses of open-label clazakizumab 160 mg IV, 4 weeks apart (Day 0 and Week 4 of radiation); these subjects were not eligible for the randomized portion of the study. Subsequent to completion of the safety run-in, eligible subjects were randomized 1:1:1 to treatment with 2 doses of clazakizumab 160 mg, or clazakizumab 320 mg, or placebo, administered IV 3 weeks apart (Day 0 and Week 3 of radiation therapy). All subjects were to be followed for 4 weeks post last day of radiotherapy treatment for the primary efficacy and safety assessments and then for up to an additional 12 months of long-term follow-up.

Conditions

Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Open Label ALD518

Group Type: EXPERIMENTAL

ALD518

Intervention Type: BIOLOGICAL

IV

ALD518 Dose 1

Group Type: EXPERIMENTAL

ALD518

Intervention Type: BIOLOGICAL

IV

ALD518 Dose 2

Group Type: EXPERIMENTAL

ALD518

Intervention Type: BIOLOGICAL

IV

Placebo

Group Type: PLACEBO_COMPARATOR

0.9% saline

Intervention Type: DRUG

IV Infusion

Interventions

ALD518

IV

Intervention Type: BIOLOGICAL

0.9% saline

IV Infusion

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Smith, MD FRCP

Role: STUDY_DIRECTOR

Alder Biopharmaceuticals, Inc.

Locations

Morton Plant Mease Health Care

Clearwater, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Detroit Clinical Research Center

Farmington Hills, Michigan, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Mount Sinai School of Medicine

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Cancer Specialists of Southern Texas

Corpus Christi, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

VA Puget Sound Health Care Syatem

Seattle, Washington, United States

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Royale Brisbane and Women's Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Adelaide Radiotherapy Centre

Adelaide, South Australia, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

LKH Graz, HNO Ambulanz

Graz, , Austria

Univ. Klinik fur Innere Medizin III

Salzburg, , Austria

Hanusch Krankenhaus

Vienna, , Austria

Cancer Centre of Southeastern Ontario

Kingston, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

CHUQ-L'Hotel-Dieu de Quebec

Québec, , Canada

Uniklinik Koln

Cologne, , Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, , Germany

University Medical School, Saarland

Homburg, , Germany

A.O. San Paolo - Polo Universitario

Milan, , Italy

Istituto Nazionale dei tumari

Milan, , Italy

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Udine, , Italy

Countries

United States; Australia; Austria; Canada; Germany; Italy

Other Identifiers

ALD518-CLIN-009

Identifier Type: -

Identifier Source: org_study_id