CTRI/2019/06/019649
Recruiting
Phase 2
A Phase II Clinical Study to evaluate the efficacy and safety of NRC-2694-A in patients with recurrent Head and Neck Squamous Cell Carcinoma
ATCO Pharma Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Sponsor
- ATCO Pharma Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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