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
- Subjects With Head and Neck CancerMedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002669-40-IT
- Lead Sponsor
- ALDER BIOPHARMACEUTICALS INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
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 Ethics 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 management (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) 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. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue or soft palate), with each site receiving = 55 Gy 4. 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) 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 × 109/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 8. 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: 0
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
1.Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor 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; or anticipation of need for a major surgical procedure during the clinical trial 9. Active infectious disease, excluding oral candidiasis 10. Have a previous history of tuberculosis or histoplasmosis 11. Have active tuberculosis or histoplasmosis infection 12. Use of nimesulide 13. Have OM at the screening visit 14. Have a diagnosis of autoimmune disease requiring chronic immunosuppression 15. Known seropositivity for HIV, HBV or HCV 16. Prior use of ALD518 or other monoclonal antibody 17. 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 18. Have a history of hypersensitivity to monoclonal antibodies 19. Unable to give informed consent or comply with clinical trial requirements, including completing the subject diary and PRO instruments 20. Have any past or current, acute or chronic concurrent medical condition 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method