Clinical Trials Logo
  1. Home
  2. Oral Mucositis
  3. NCT01403064

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

Oral Mucositis Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01403064
Study type Interventional
Source CSL Behring
Contact
Status Terminated
Phase Phase 2
Start date July 2011
Completion date March 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT02229136 - Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus Phase 2
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Enrolling by invitation NCT02662374 - Oral Hygiene Regimen in Patients on HCT Phase 4
Completed NCT00938080 - Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck Phase 1
Completed NCT00756951 - Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer Phase 2
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Not yet recruiting NCT05059613 - Thalidomide With or Without Probiotics in Radioactive Oral Mucositis N/A
Completed NCT04440930 - White Tea for Prevention of Chemotherapy Induced Mucositis N/A
Completed NCT05705622 - The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients N/A
Completed NCT02399228 - A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis Phase 2
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Active, not recruiting NCT01772706 - Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03689712 - ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients Phase 3
Terminated NCT02539342 - Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy Phase 3
Completed NCT02555501 - Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy Phase 3
Completed NCT01789658 - Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation N/A
Completed NCT00790322 - Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy Phase 3
Recruiting NCT00549952 - Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients N/A
Completed NCT00289003 - The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients Phase 2