EUCTR2015-002222-40-BE进行中（未招募）1 期
Randomized, Placebo-Controlled, Double Blind Phase 2 Study of Patritumab (U3-1287) in Combination with Cetuximab plus Platinum Based Therapy in First Line Setting in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult subjects =18 years old
- •2. Histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx,and larynx
- •3. Heregulin expression level is required
- •- Samples must be taken from subjects who have recurrent or metastatic disease. These samples can be from either rec/met archived or fresh biopsy samples
- •- No cancer treatment between time of biopsy and submission of sample
- •- Surgical or core needle biopsy is acceptable
- •- Fine-needle aspiration or cytology is not acceptable for biopsies
- •4. Human papilloma virus (HPV) status or p16 (surrogate for HPV) is required. These results must come from tumor tissue. These results may be obtained from either a local lab or samples sent to the central lab
- •- HPV or p16 status can be from any tumor biopsy material from initial diagnosis
- •5. Measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1
- •6. Eastern Cooperative Oncology Group performance status 0 or 1
- •7. Hematological function, as follows:
- •- Absolute neutrophil count = 1.5 x 109/L
- •- Platelet count = 100 x 109/L
- •- Hemoglobin = 10 g/dL
- •8. Renal function, as follows:
- •- Estimated serum creatinine clearance (mL/min) or glomerular filtration rate (GFR) = 60 mL/min for cisplatin and = 30 mL/min for carboplatin
- •9. Hepatic function, as follows:
- •- Aspartate aminotransferase = 2.5 x upper limit of normal (ULN) (if liver metastases are present, < 5 x ULN)
- •- Alanine aminotransferase = 2.5 x ULN (if liver metastases are present, < 5 x ULN)
- •- Alkaline phosphatase = 2.0 x ULN (if bone or liver metastases are present, < 5 x ULN)
- •- Bilirubin = 1.5 x ULN
- •10. Prothrombin time or partial thromboplastin time = 1.5 x ULN
- •11. Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to enrollment (where demanded by local regulations, test may be required within 72 hours prior to enrollment)
- •12. Adult subjects of child-bearing potential must agree to use double barrier contraceptive measures. Two of the following precautions must be used:
- •bilateral vasectomy, bilateral tubal ligation, intrauterine device (IUD), combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine hormone-releasing system (IUS), condom with spermicide, abstinence. These contraception measures must be used for the entire duration of the study and for 6 months after the last study dose is received
- •13. Subjects must be willing and able to comply with schedule visits, treatment plan, laboratory tests, and other study procedures
- •14. Provided written informed consent(s)
- •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 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Left ventricular ejection fraction (LVEF) <50%
- •2. Prior EGFR targeted regimen
- •3. No HRG expression result
- •4. No HPV or p16 status
- •5. Prior anti-HER3 therapy
- •6. Prior chemotherapy for recurrent/metastatic disease
- •7. Anti-cancer therapy between biopsy and submission of sample
- •8. Presence of squamous cell tumors of the nasopharynx
- •9. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for = 2 years
- •10. Known history of brain metastases or active brain metastases
- •11. Uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)
- •12. Clinically significant electrocardiograph (ECG) findings
- •13. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- •14. Platinum-containing drug therapy with radiotherapy less than 6 months before
- •study drug treatment
- •15. Therapeutic or palliative radiation therapy or major surgery within 4 weeks before
- •study drug treatment. Radiation treatment to all sites of measureable disease unless progression is documented after radiation
- •16. Participated in clinical drug trials within 4 weeks before study drug treatment. Current participation in other investigational procedures
- •17. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known HIV infection, or active hepatitis B or C infection or undergoing medical treatment for infection
- •18. Uncontrolled type 1 or 2 diabetes mellitus
- •19. Known hypersensitivity or allergic reaction against any of the components of the
- •trial treatment
- •20. Pregnant, breastfeeding, or unwilling/unable to use acceptable contraception
- •21. Residual toxicities = Grade 1 from previous therapies that the Investigator determines would exclude participation
- •22. Psychological, social, familial, or geographical factors that would interfere with study participation or follow-up
- •23. Committed to an institution by virtue of an order issued either by judicial or administrative authorities
- •24. Employee or immediate relative of an employee of the sponsor, CRO, the study center, or their affiliates or partners
- •25. Receiving yellow fever vaccine or live attenuated vaccines (for subjects
- •receiving carboplatin)
- •26. Presence of hemorrhagic tumors (for subjects receiving carboplatin)
- •27. Prophylactic use of phenytoin or fosphenytoin (for subjects receiving
- •cisplatin or carboplatin)
研究者
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