A clinical trial to study the effects of two drugs, R-TPR-033 and Erbitux® in patients with head and neck cancer of squamous cell type that has spread to other part of the body
- Conditions
- Health Condition 1: null- Patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.
- Registration Number
- CTRI/2015/06/005909
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 28
1.Patients of 18-65 years of age.
2.Histologically or cytologically confirmed recurrent locoregional or metastatic squamous-cell carcinoma of the head and neck that is not suitable for
local therapy
3.Patients must have documented progression of platinum-based chemotherapy for R/M disease
4.At least one lesion that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
5.Eastern Cooperative Oncology Group (ECOG) performance status <=2.
6.Estimated life expectancy >4 months
7.ANC >=1.5x109/L, Platelets >=100x109/L, Hemoglobin >9.0 g/dL, Serum Creatinine <= 1.5 ULN and Total bilirubin <= 1.5 mg/dL.
8.INR and aPTT <=1.5Ã? ULN.
9.Serum creatinine <=1.5Ã? ULN, or creatinine clearance >=50 mL/min
10.Patient or Legally Acceptable Representative able to comprehend and give written informed consent for the study and willing to come for follow-up visits as per protocol requirements
1. Nasopharyngeal cancer
2. Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
3. Last anti-tumor therapy within 4 weeks before Cycle 1, Day 1.
4. Diagnosis of concurrent second malignancy or leukemia
5. Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
6. Symptomatic hypercalcemia.
7. History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
8. Active hemoptysis
9. Clinically significant gastrointestinal bleeding within 6 months prior to Cycle 1
10. History of Interstitial Lung Disease
11. History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies.
12. Clinical or Radiological evidence of Primary central nervous system malignancy or
13. Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization
14. Severe dyspnoea
15. Pre-existing grade 2 or greater motor or sensory neuropathy
16. Women who are pregnant, lactating, or women of childbearing potential who are not using effective contraception.
17. Serious underlying medical condition.
18. Subject participation in another clinical trial within 90 days prior to administration of IP.
19. Previous use of non-human monoclonal antibody therapy
20. Current severe, uncontrolled acute or chronic systemic disease
Any other condition which investigator feels would pose a significant hazard to subject, if IP is administered.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome Name: Efficacy will be assessed as BOR (Best Overall Response) by RECIST 1.1 criteriaTimepoint: week 18
- Secondary Outcome Measures
Name Time Method â?¢To assess efficacy as Disease Control Rate <br/ ><br>â?¢To determine disease progression free survival (PFS) rate <br/ ><br>â?¢Objective Response Rate <br/ ><br>â?¢To determine duration of objective response To determine time to progression <br/ ><br>â?¢To evaluate Overall Survival (OS) <br/ ><br>â?¢Pharmacokinetics of R-TPR-033 and ErbituxR <br/ ><br>â?¢Evaluation of safety <br/ ><br>â?¢Pharmacodynamic studies of anti-EGFR activity <br/ ><br>â?¢To study immunogenicity <br/ ><br>Timepoint: week 24