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Bioequivalence study in Metastatic Colorectal Cancer Patients

ABSTRACT: 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 water at ambient temperature after an overnight fast of at least 10 hours Prior to morning dosing and fasting of at least 02 hours prior to evening dosing (except the standard test meal administered 30 minutes prior to dosing) within 30 minutes of completion of morning and evening meals on Cycle 1 (Days 1 through 5) OR Cycle 1 (Day 8 through 12) or Cycle 2 (Days 1 through 5) based on the randomization Schedule. Control Intervention1: LONSURF Tablet; 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. Princeton, NJ 08540 USA. orally twice daily with approximately 240 mL (8 fluid ounces) of water at ambient temperature after an overnight fast of at least 10 hours Prior to morning dosing and fasting of at least 02 hours prior to evening dosing (except the standard test meal administered 30 minutes prior to dosing) within 30 minutes of completion of morning and evening meals on Cycle 1 (Days 1 through 5) OR Cycle 1 (Day 8 through 12) or Cycle 2 (Days 1 through 5) based on the randomization Schedule Primary outcome(s): 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

DISEASE(S): Malignant Neoplasm Of Colon, Unspecified

PROVIDER: 2586699 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention1: Capecitabine Tablets USP 500 mg: Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Dr. Reddys Laboratories, India The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be reference listed drug XelodaÂ (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) and doses for the remainder treatment cycle will be locally approved and marketed drug. The morning and evening dose will be based on BSA. The BSA will be calculated for the patient 12 hours prior to dosing on Day 1 and the same will be used for the dosing on Day 2 as well. Control Intervention1: XelodaÂ (capecitabine) Tablets 500 mg: Each tablet contains: Capecitabine 500 mg Distributed by: Roche Laboratories Inc., New Jersey 07110-1199 The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be reference listed drug XelodaÂ (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) and doses for the r Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Dr. Reddys Laboratories, India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Distributed by Roche Laboratories Inc., USA) in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Other Method of allocation concealment:Centralized Blinding and masking:Open Label

Project description:Intervention1: Capecitabine Tablets USP 500 mg Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Intas Pharmaceuticals Ltd, India. : The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s. Control Intervention1: XelodaÂ (capecitabine) Tablets 500 mg Each tablet contains: Capecitabine 500 mg Distributed by: Roche Chemical and Pharmaceutical Products SA, Brazil : The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s. Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, India)] relative to that of reference formulation [XelodaÂ(capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., Brazil)] in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label

Project description:Interventions: Irinotecan (180mg/m2), and Panitumumab (6mg/Kg), will be administered intravenously (IV) on Day 1 of every 14 day cycle. Trifluridine/tipiracil will be administered orally (PO) twice a day (BD) on Days 1-5 of every 14 day cycle. Trifluridine/tipiracil will be supplied as 15 mg (comprising 15 mg trifluridine/6.14 mg tipiracil) and 20 mg (comprising 20 mg trifluridine/8.19mg tipiracil) immediate-release film-coated tablets and the number of tablets needed to achieve the assigned dose will be determined according to the patient’s body surface area. Dosing of trifluridine/tipiracil in the dose escalation phase (phase Ib) will be as follows: Dose LevelTrifluridine/tipiracil 1 (starting dose)25 mg/m2 orally, BD 2 30 mg/m2 orally, BD 3 35 mg/m2 orally, BD The dose escalation phase (phase Ib) will recruit participants who have received and failed one prior chemotherapy regimen for metastatic colorectal cancer (mCRC). It is anticipated that this phase of the study will take 6 months to complete. The maximum (MTD) will be assessed during the dose escalation phase, where participants will be enrolled in cohorts. Each cohort will consist of a minimum of 3 newly enrolled evaluable patients. If there is no dose-limiting toxicities (DLT) in the first 3 patients within a cohort, a new cohort at the next dose level will commence. If safety data show one patient in a cohort experiencing a DLT, then the cohort will be increased to a maximum of six evaluable patients. If no more than one of the six patients experiences a DLT, then the next dose level may be evaluated. If two or more patients entered in any cohort experience a DLT, then the MTD has been exceeded, and the previous dose level will be considered the MTD. If no dose level has 2 or more DLT`s, then dose level 3 will be considered the MTD. A minimum of 6 evaluable patients will be treated at the dose level before the dose can be declared as the MTD and enrolment into the phase II component can begin. Cohorts may also be expanded at any dose level to further assess safety parameters as required. If a dose level is opened and patients in the previous cohort subsequently develop unexpected toxicities the cohort will be closed and the previous cohort will be re-assessed with further patients enrolled into the previous cohort as required. The maximum tolerated dose (MTD) of tipiracil/trifluridine will be the dose level administered in the expansion phase (phase II). The expansion phase (phase II) will recruit participants that have received no prior treatment for mCRC, and is anticipated to take up to 18 months to complete. Treatment will continue until disease progression or withdrawal criteria are met.

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Bioequivalence study in Metastatic Colorectal Cancer Patients

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