Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil Tablet.: Manufactured by NATCO Pharma Ltd. orally twice daily with approximately 240 mL (8 fluid ounces) of
35 mg/m2 of Trifluridine
Tipiracil Tablet(15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil tablet ): Manufactured by Taiho Pharmaceutical Co., Ltd., Japan. Manufactured for Taiho Oncology, Inc. P
Sponsors
NATCO Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant or non-lactating females of age between 18 to 65 years (both inclusive). 2. Completed the screening process within 14 days prior to Period I dosing. 3. Body mass index (BMI) between 17.0 kg/m2 to 30.0 kg/m2, inclusive for Patients calculated as (weight in kg) / (height in m)2 4. Patient has understood and signed the informed consent form to participate in the study. 5. Patients must have/have had histopathologically/cytologically confirmed Metastatic (Stage IV) colorectal cancer with measurable metastatic disease according to RESIST v. 1.1. 6. Patient must have received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for Metastatic Colorectal Cancer. 7. Eastern Cooperative Oncology Group (ECOG) performance status 8. Patient with adequate bone marrow, renal and hepatic function. 9. Life expectancy >= 3 months 10. Patient with adequate organ function • Absolute neutrophils count (ANC) >= 1.5 x 109/L • Haemoglobin >= 10 g/dl • Platelets (PLT) >= 75 x 109/L • AST/ALT • Bilirubin • Serum Creatinine 11. No scheduled/planned Radiotherapy or surgery during the course of the study. 12. In case of female patient the serum pregnancy test at screening visit must be negative. 13. Females of Child bearing potential must be willing to use adequate contraception (as defined below) throughout the study and continuing at least 3 months after the last dose of the study drug. For this study, acceptable and effective methods of contraception for females included i. Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, ii. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or iii. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner). 14. For male Patients, one of the following must apply in order to avoid impregnating a female partner, from the first study dose and agree to follow throughout the study and for at least 3 months following the last dose of the study. i. Abstinent ii. Use of barrier method with spermicide 15. Patient is willing to be available for the entire study period and to adhere to protocol requirements as evidenced by signing informed consent document.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess relative bioavailability of 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil Tablet, compared to LONSURF (15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil) Tablet, following multiple dose in Metastatic colorectal cancer patients who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy.Timepoint: 33 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of the test and reference products in Metastatic colorectal cancer patientsTimepoint: 33 Days | — |
Countries
India
Contacts
Public ContactSachin Pawar
Accutest Research Laboratories (I) Pvt.Ltd.
Outcome results
None listed