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Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

ABSTRACT: Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

DISEASE(S): Colorectal Cancer

PROVIDER: 2611187 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Interventions: investigational material(s) Generic name etc : Lonsurf combination tablet T15/T20 INN of investigational material : trifluridine + tipiracil hydrochloride Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

| 97953 | ecrin-mdr-crc

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab

Project description:Interventions: 1 cycle is 28days. Lonsurf(25mg/m2)is administered orally twice daily in 1-5days and 8-12 days. Irinotecan(100mg/m2) and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. Primary outcome(s): Recommended dose:RD Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

| 2615622 | ecrin-mdr-crc

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

| 2634299 | ecrin-mdr-crc

ALTAIR study

Project description:Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. Primary outcome(s): efficacy Disease-Free Survival 1 (DFS1) The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary large intestine carcinoma lesion other than a relapse (an intramucosal cancer lesion will not be treated as an event) that is confirmed after the date of enrollment, and death from any cause. In principle, events will be assessed by the investigator. Study Design: This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.

| 2658591 | ecrin-mdr-crc

First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors

Project description:Study HS-CA102N-101 is a phase 1, two part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors. CA102N will be evaluated in subjects with locally advanced or metastatic solid tumours for which no effective therapy is available in Part 1 (dose escalation) and in subjects with relapsed or refractory locally advanced or metastatic colorectal cancer (mCRC) after prior oxaliplatin and irinotecan-based chemotherapy in Part 2 (dose expansion).

| 2279951 | ecrin-mdr-crc

Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Intervention name : trifluridine/tipiracil INN of the intervention : trifluridine/tipiracil Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Intervention name : bevacizumab INN of the intervention : bevacizumab Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. Control intervention name : fluorouracil INN of the control intervention : fluorouracil Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium) INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium) Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 2611617 | ecrin-mdr-crc

A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy.

Project description:Interventions: Lonsurf/L-OHP therapy Lonsurf: 70mg/m2, d1-5, d15-19 (fixed dose) L-OHP: 50-85mg/m2, d1,d15 (dose escalation) every 4 weeks Primary outcome(s): [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part]Disease Control Rate (DCR) Study Design: Single arm Non-randomized

| 2631090 | ecrin-mdr-crc

A randomized phase II study of pulsatile high-dose sunitinib versus TAS-102 in patients with metastatic colorectal carcinoma (mCRC).

Project description:Interventions: A: TAS-102 (Lonsurf) 35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period. B: Experimental: High Dose Intermittent Sunitinib 700 mg once every 2 weeks. Primary outcome(s): The primary objective of this study is to improve progression free survival (PFS), of patients with metastatic colorectal carcinoma (mCRC) treated with high-dose sunitinib once every 2 weeks to 5 months, compared to the reported 2 months for TAS-102 monotherapy. Study Design: Randomized controlled trial, Open (masking not used), Active, Parallel

| 2442614 | ecrin-mdr-crc

Bioequivalence study in Metastatic Colorectal Cancer Patients

Project description: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

| 2586699 | ecrin-mdr-crc

Study on the effects of metformin and cimetidine on the exposure of trifluridine/tipiracil (lonsurf) in patients with a metastatic colorectal carcinoma

Project description:Primary objectives: 1. To determine the possible drug interaction between Lonsurf and metformin on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer.2. To determine the possible interaction between Lonsurf and cimetidine on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer. of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure. Primary endpoints: To determine the influence of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.

| 2538861 | ecrin-mdr-crc

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