A clinical trial to study the safety and efficacy of biosimilar cetuximab in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck.
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2019/09/021256
- Lead Sponsor
- Enzene Biosciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of 18-65 years of age at the time of signing the ICF
2.Has life expectancy of at least 6 months from screening
3. Histologically confirmed diagnosis of SCCHN
4. Presence of recurrent locoregional (not suitable for local therapy) or metastatic disease as per Tumor Node Metastasis staging at screening
5. In case of recurrent locoregional carcinoma, patients must have documented progression of platinum-based chemotherapy for recurrent disease
6. Has at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening
7. Eastern cooperative oncology group (ECOG) status 0 to 2 at screening
8. Willing and able to comply with the protocol
9. Willing to provide written informed consent
1.Patients with Nasopharyngeal cancer
2.Prior systemic chemotherapy (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening)
3.Patient who has received cetuximab or other EGFR targeting agent treatment (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening)
4.Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization
5.Concomitant anti-tumor therapy or concomitant immunotherapy
6.Known sensitivity to any component of the investigational product (IP) and medication used in this study
7.Clinical evidence of brain metastasis or leptomeningeal involvement
8.History of Interstitial Lung Disease
9.History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies
10.Patientââ?¬•s having the following laboratory results at screening
a.Absolute neutrophil count (ANC) < 1,500/mm3
b.Hemoglobin (Hb) < 9 g/dL
c.Total Leucocyte count < 3000/mm3
d.Platelet count < 100,000/mm3
e.Total bilirubin level > 1.5 times the upper limit of the normal laboratory range (ULN)
f. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels � 5 times ULN
g.Serum Creatinine level > 1.5 times ULN
h.Abnormal serum electrolytes (within normal limit)
i. INR and aPTT (within normal limit)
11.Patients suffering from acute or chronic infection(s)
12.Myocardial infarction within 6 months prior to screening
13.Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening
14. Pre-existing grade 2 or greater motor or sensory neuropathy
15. Active hemoptysis (defined as bright red blood of �½ teaspoon or more in saliva) within 30 days prior to randomisation.
16.History of clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention (e.g., variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within 6 months prior to randomisation.
17.Patients with history of keratitis
18.Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening
19.Female patients of childbearing potential not willing to implement adequate non-hormonal contraceptive measures during the study period
20.Patients who are pregnant or nursing
21.Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study
22.Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To compare the efficacy of biosimilar cetuximab versus innovator cetuximab in patients with recurrent locoregional or metastatic SCCHN by assessment of Disease Control <br/ ><br>Rate (DCR) <br/ ><br>2.To compare the efficacy of biosimilar cetuximab versus innovator cetuximab in patients with recurrent locoregional or metastatic SCCHN by assessment of overall response <br/ ><br>rate (ORR)Timepoint: 1. All patients completed 12 week of treatment <br/ ><br>2. All patients completed 18 weeks of treatment
- Secondary Outcome Measures
Name Time Method 1. Pharmacokinetics (PK) of biosimilar versus innovator cetuximab <br/ ><br>2.Immunogenicity of biosimilar cetuximab and innovator cetuximab by assessment of <br/ ><br>anti-cetuximab antibody (ADA) <br/ ><br>Timepoint: Anti-cetuximab antibody (ADA): baseline and Week 18 visit <br/ ><br>PK Assessment:Baseline, Week2,3 and 4 <br/ ><br>