Squamous Cell Carcinoma of the Head and Neck MedDRA version: 20.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Patritumab
Product Code: U3-1287
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: patritumab
CAS Number: 1262787-83-6
Current Sponsor code: U3-1287
Other descri
Sponsors
Daiichi Sankyo , Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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, =65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1. Left ventricular ejection fraction (LVEF) 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy. ;Secondary Objective: • Evaluate overall survival (OS) • Evaluate overall response rate (ORR) • Refine the cutoff between heregulin high and low expression based on clinical data from this study • Assess the population PK of patritumab in subjects with SCCHN • Assess the PK parameters of serum cetuximab and platinum concentrations when cetuximab and cisplatin or carboplatin (platinum-based therapy) are coadministered with patritumab in a sub group (n = 30) of subjects • Evaluate the incidence of human antihuman antibody (HAHA) formation (anti-patritumab antibodies) • Evaluate the safety and tolerability of the combination of patritumab + cetuximab + platinum-based therapy in first-line treatment of subjects with SCCHN;Primary end point(s): 1) Progression free survival (PFS) in the HRG high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy;Timepoint(s) of evaluation of this end point: 1) The time from the date of randomization to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1 as assessed by investigator) or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2) Overall survival (OS) 3) Objective response rate (ORR) 4) PK parameters of serum cetuximab and platinum concentrations when cetuximab and cisplatin or carboplatin are coadministered with patritumab in a subgroup (n=30) of subjects 5) Population PK of patritumab 6) Incidence of HAHA formation (anti-patritumab antibodies) 7) Safety and tolerability of the combination of patritumab + cetuximab + platinum-based therapy in first-line treatment of subjects with SCCHN;Timepoint(s) of evaluation of this end point: 2) Date of randomization to death due to any cause 2) Subjects alive at time of data cut off for OS analysis will be censored at the last contact date at which subject is known to be alive 3) Proportion of subjects with the best ORR of CR or PR regardless of whether it is confirmed or unconfirmed 4) Refer to schedule of events 5) Refer to schedule of events 6) Refer to schedule of events 7) Refer to schedule of events | — |
Countries
Belgium, France, Germany, Hungary, Poland, Romania, United Kingdom
Contacts
Public ContactClinical Trial Information Contact
Daiichi Sankyo , Inc.
Outcome results
None listed