A clinical trial studying the safety and effectiveness of the study drug ALD518 for treating oral mucositis in patients with head and neck cancer who are currently receiving chemotherapy and radiotherapy

• Conditions: Oral Mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy; MedDRA version: 14.1Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002669-40-AT
• Lead Sponsor: Alder BioPharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Willing and able to understand and sign an Informed Consent Form (ICF) for the clinical trial approved by the Investigator’s local or a central Institutional Review Board (IRB) or Ethic Committee (EC)
2. 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 (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) management are eligible
3. 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 at each site. Planned radiation treatment fields must include at least 2 oral sites (retromolar trigone, buccal mucosa, floor of mouth, tongue, or soft palate), with each site receiving = 55 Gy
4. Have a plan to receive a standard cisplatin or carboplatin CT regimen
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status = 1
6. CRP < 80 mg/L
7. Have adequate hematopoietic, hepatic, and renal function at the screening visit:
Hematopoietic function
• Hemoglobin = 10 g/dL
• Absolute neutrophil counts (ANC) = 1,500 cells/mm3
• Platelet count = 100 × 10^9/L
Hepatic function
• Total bilirubin = 1.25 times the upper-normal limit (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 1.5 times the ULN
Renal function: Serum creatinine concentration = 2 mg/dL; if result is = 1.4 mg/dL and = 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site’s local laboratory. To be eligible for the clinical trial, a subject must demonstrate a 24-hour urinary creatinine clearance = 50 mL/min or via Cockcroft- Gault calculation
8. Are not breastfeeding, are not pregnant, and do not plan to become pregnant during the clinical trial
9. Females with childbearing potential must provide a negative pregnancy test within the screening period and must be using adequate contraception (oral or injectable [depot] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm or spermicidal gel]). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before clinical trial start
10. Males or females aged 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor, or tumor invasion of a major blood vessels
2. Metastatic disease (M1) Stage IV C
3. Any prior history of head and neck cancer
4. Prior radiation to the head and neck
5. Plan to be treated with cetuximab (Erbitux®)
6. Have undergone induction CT
7. History of non-head and neck malignant tumors, excluding non-melanoma skin cancer or
curatively excised in situ cervical carcinoma within the last 5 years
8. Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the clinical trial
9. Active infectious disease, excluding oral candidiasis
10. Have a previous history, or exposure to active tuberculosis or histoplasmosis infection
11. Have active tuberculosis or histoplasmosis infection
12. Have OM at the screening visit
13. Have a diagnosis of autoimmune disease requiring chronic immunosuppression, e.g. methotrexate
14. Known seropositivity for HIV, HBV or HCV
15. Prior use of ALD518 or other monoclonal antibody
16. Have received any experimental, unregistered therapy (within or outside a clinical trial) within 30 days or five plasma half lives (whichever is longer) before dosing
17. Unable to give informed consent or comply with clinical trial requirements, including completing the subject diary and PRO instruments
18. Have any past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the clinical trial or unable to comply with follow-up visits
19. Subjects who have a history of known symptomatic diverticulosis, diverticulitis, perforated diverticular diseases, or small bowel and/or upper GI perforation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified