A study comparing E7050 and Cetuximab to Cetuximab alone for the treatment of head and neck cancer
- Conditions
- Squamous Cell Carcinoma of the Head and NeckMedDRA version: 14.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000773-31-GB
- Lead Sponsor
- Eisai Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 95
Patients may be entered in the study only if they meet all of the following criteria:
1. Male or female patient =18 years of age;
2. Histologically or biologically confirmed, platinum-resistant (defined as failure to respond to treatment with a platinum agent or recurrence of disease after initial response to platinum within 12 months of completing therapy), locally advanced, recurrent and/or metastatic SCCHN, which is untreatable by surgical resection or radiation therapy;
3. Recovery from prior treatment toxicity to Baseline or Grade 1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v. 4.0);
4. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1) criteria;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 2;
6. For patients with hypertension, it must be well controlled. If a patient presents with poorly controlled hypertension, defined as a mean systolic blood pressure =140 mm Hg or mean diastolic blood pressure =90 mm Hg, antihypertensive medication(s) should be initiated or adjusted with a goal to control the blood pressure <140/90 mm Hg. Blood pressure must be reassessed on 2 occasions, consecutively, that are separated by a minimum of 24 hours;
7. Adequate hematologic, renal, liver, and coagulation system function as defined by laboratory values performed within 21 days prior to initiation of dosing:
Absolute neutrophil count (ANC) =1.5 x 109/L;
Platelet count =100 x 109/L;
Hemoglobin =8 g/dL(a hemoglobin <9.0 g/dL at Screening is
acceptable if it is corrected to =9 g/dL by growth factor or
transfusion prior to the first dose);
Serum creatinine =1.5 X times the upper limit of the normal (ULN)
and/or creatinine clearance =50 mL/min per the Cockcroft and Gault
formula;
Total serum bilirubin =1.5 X ULN (except for Gilbert’s syndrome
patients), serum aspartate transaminase (AST/SGOT) or serum
alanine transaminase (ALT/SGPT) =2.5 X ULN, and =5 X ULN if liver
metastases are present. If there are bone metastases, liver-specific
alkaline phosphatase may be separated from the total and used to
assess liver function;
PT/International normalized ratio (INR) =1.5 X ULN
PTT =1.1 X ULN;
8. Adequate recovery from major surgery prior to study treatment;
9. Male or female patients of childbearing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment;
10. Females of childbearing potential must have a negative serum pregnancy test at Screening;
11. Females may not be breastfeeding;
12. Ability to understand and willingness to sign a written informed consent.
Are th
Patients will not be entered in the study for any of the following reasons:
1. Nasopharyngeal tumors;
2. Prior treatment with E7050, its chemical derivatives, or prior anti-c-Met therapy;
3. Received chemotherapy, targeted therapy, radiotherapy, surgery, or immunotherapy within the 4 weeks prior to commencing study treatment or have not recovered from all treatment-related toxicities to Grade =1, except for alopecia;
4. Prior anti-EGFR therapy (for Phase Ib, prior cetuximab, alone or in combination, is allowed but it must not be within 4 weeks prior to first day of study-defined treatment). In Phase II, prior therapy with cetuximab is permitted only if administered in combination with radiotherapy and must not be within 4 weeks prior to first day of study-defined treatment;
5. Prior anti-angiogenic therapy (permitted in Phase Ib);
6. Known hypersensitivity to Chinese hamster ovary products or recombinant human antibodies;
7. History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, or b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for =3 years;
8. Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
9. Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade =1, except for peripheral neuropathy (Grade 1 and Grade 2 are permitted) and alopecia;
10. Are currently receiving any other anti-cancer treatment, aside from control of symptoms;
11. Palliative radiotherapy is not permitted throughout the study period;
12. CTCAE Grade =3 peripheral neuropathy (Grade 1 and Grade 2 are permitted);
13. Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment; Minor surgery such as Portacath placement or skin biopsy is permitted if =7 days have passed;
14. History of bleeding diathesis or coagulopathy other than due to anti-coagulation therapy;
15. History of bleeding varices;
16. Active hemoptysis (defined as bright red blood of ½ teaspoon or more) within the 30 days prior to study entry;
17. Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg, variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose;
18. History of untreated deep venous
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