Health Condition 1: null- Advanced Solid Malignancies Health Condition 2: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: NRC-2694-A: NRC-2694-A is a small molecule tyrosine kinase inhibitor demonstrated anticancer activity in preclinical models of cancer
Starting dose og the study drug is 100 mg/day give
Sponsors
NATCO Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Patients must be greater or equal to 18 years old with expected life expectancy more than 8 weeks. •ECOG Performance Score less than or equal to 2 •Patients with evaluable disease, histologically documented confirmed diagnosis of an advanced solid malignancy for whom standard treatment options did not exist •Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count greater than or equal to 2000/mm3, platelet count greater than or equal to 1,00,000mm3 and hemoglobin level 8.0 g/dL), renal function (normal serum creatinine), liver function [total bilirubin level less than or equal to 2 times upper normal limit (UNL) and serum transaminases levels less than or equal to 2.5 times UNL/ less than or equal to 5 times for liver metastasis and/or obstructive jaundice. Subjects must have tested negative for, HIV, HbsAg and pregnancy (for female subjects) •Patients must not have received chemotherapy within 14 days (6 weeks for nitrosureas or mytomycin C) and radiotherapy within 3 weeks and must not have undergone surgery within 2 weeks before dosing •Patients must be willing to practice birth control during and for 2 months after treatment
Exclusion criteria
Exclusion criteria: • Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy. • Patients with brain metastases or primary CNS malignancies. • Concurrent therapy for the cancer (Radiation therapy, chemotherapy etc) • Patients who are pregnant or lactating. • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, and which may obscure the evaluation of toxicity or alters drug metabolism • Impairment of gastrointestinal function that could significantly alter the absorption of the study drug and also the use of medication altering gastric pH (mild antacids are permitted if taken either 4 hours before or after the study drug administration)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events at each dose level will be evaluated using clinical (physical examinations, ECGs and vital signs) and safety laboratory parameters namely Hematology (complete blood count, differential count, platelet count) and Biochemistry values. All adverse events will be graded using National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE)Timepoint: Adverse events at each dose level will be evaluated using clinical (physical examinations, ECGs and vital signs) and safety laboratory parameters namely Hematology (complete blood count, differential count, platelet count) and Biochemistry values. All adverse events will be graded using National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| PharmacokineticTimepoint: Day 1 and Day 12 ;Tumor EvaluationTimepoint: Day 30, 60 and 90 | — |
Countries
India
Contacts
Public ContactG venkata Ramana
NATCO Pharma Limited
Outcome results
None listed