Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: NRC-2694-A Tablet: NRC-2694-A will be given with standard chemothearpy
Control Intervention1: Cisplatin/ Carboplatin and 5FU which are standard chemotherapeutic agents: Cisplatin On Day
Sponsors
NATCO Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must be between 18 and 65 years of age with life expectancy = 3 months having recurrent and/or metastatic disease. 2. ECOG Performance Status less than or equal to 2. 3. Histologically confirmed squamous cell carcinoma of the head and neck. Primary sites include, oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus. 4. Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count =2000/mm3, platelet count = 1,00,000mm3 and hemoglobin level 8.0 g/dL), renal function (normal serum creatinine), liver function [total bilirubin level =2 times upper normal limit (UNL) and serum transaminases levels = 2.5 times UNL/ = 5 times for liver metastasis and/or obstructive jaundice]. 5. Patients must not have received chemotherapy within 30 days (6 weeks for nitrosoureas or mytomycin C) and radiotherapy within 3 weeks and must not have undergone surgery within 2 weeks before dosing. 6. Measurable lesion as per Revised RECIST criteria (1.1 version) 7. Subjects who received primary radiation therapy are eligible if the locoregional recurrence is in the field of radiation and occurred at least 6 months after therapy completion. If the recurrence is outside the field of radiation, subject will be eligible at least 3 months after therapy completion. 8. Willing to practice birth control during and for 2 months after treatment. 9. Patients must be tested negative for HIV, HbsAg and pregnancy (for female subjects).
Exclusion criteria
Exclusion criteria: 1. Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy 2. Patients with brain metastases or primary CNS malignancies. Radiological evaluation of brain metastasis will be performed only if the patient has symptoms 3. Prior EGFR-targeting therapies, prior investigational agents for recurrent or metastatic disease, other concurrent investigational agents, other concurrent anticancer treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Tumor response will be assessed by CT or MRI at baseline and at end of every 6-week (Before start of Preceding cycle) after the start of treatment until disease progressionTimepoint: 1, 42, 84 and 216 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival is defined as the time from the date of randomization to the date of death (regardless of the cause of death combines). Percentage of patients in each arm achieving Objective response (complete and partial response), duration of response (DOR; time from first confirmed object response to disease progression), time to response (TRR; time from randomization to first confirmed objective response)Timepoint: day 1 and day 216 | — |
Countries
India
Contacts
Public ContactDr G Venkat Ramana
NATCO Pharma Ltd
Outcome results
None listed