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Phase II study of TAS-102 in patients with metastatic colorectal cancer

ABSTRACT: Intervention name : TAS-102 Dosage And administration of the intervention : TAS-102 70 mg/m2 was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. Primary outcome(s): Overall survival To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study

DISEASE(S): Patients With Non- Resectable Advanced Metastatic Colorectal Cancer Refractory Or Intolerable To Fluoropyrimidine, Irinotecan And Oxaliplatin, Who Had A History Of Chemotherapy Of 2 Or More Regimens

PROVIDER: 2610203 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II study of TAS-102 in patients with metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : TAS-102 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TAS-102 70 mg/m2 was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. Primary outcome(s): Overall survival To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study

| 99901 | ecrin-mdr-crc

A phase I study of TAS-102 and irinotecan

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). Control intervention name : irinotecan INN of the control intervention : irinotecan Dosage And administration of the control intervention : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

| 2610898 | ecrin-mdr-crc

A phase I study of TAS-102 and irinotecan

Project description:Interventions: investigational material(s) Generic name etc : TAS-102 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). control material(s) Generic name etc : irinotecan INN of investigational material : irinotecan Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

| 100929 | ecrin-mdr-crc

A Pharmacogenomics Study of TAS-102

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met. Primary outcome(s): Correlation between the relative factor and disease control rate, overall survival, or progression-free survival RECIST (ver.1.1) Study Design: Multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study

| 2610782 | 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 for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with colorectal cancer (APOLLON)

Project description:Intervention name : panitumumab, TAS-102 INN of the intervention : panitumumab, trifluridine + tipiracil Dosage And administration of the intervention : Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m^2 given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course). Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety Number of Participants With Dose Limiting Toxicity (DLT) with Panitumumab plus TAS-102 Combination Therapy Timeframe: Up to approximately 1 month DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant. efficacy Progression Free Survival (PFS) Rate at 6 Months Timeframe: Up to 6 months PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. Study Design: Exploratory Study

| 2611401 | ecrin-mdr-crc

A phase II study of TSU-68 in patient with metastatic colorectal cancer

Project description:Intervention name : TSU-68, S-1, Oxaliplatin INN of the intervention : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin Dosage And administration of the intervention : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. Additionally for the patients of group A, TSU-68 is orally administered at 200 mg twice a day after meals on day 1 to 21. Control intervention name : S-1, Oxaliplatin INN of the control intervention : S-1: tegafur, gimeracil, oteracil potassium oxaliplatin Dosage And administration of the control intervention : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. Primary outcome(s): Progression free survival RECIST (ver. 1.1) Study Design: Open-label, multicenter, randomized phase II study

| 2610479 | ecrin-mdr-crc

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

Project description: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

| 2611187 | ecrin-mdr-crc

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Intervention name : LV (Levofolinate calcium) INN of the intervention : folic acid Dosage And administration of the intervention : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest. Primary outcome(s): Efficacy, Safety Study Design: Open-label, Multi-center Study

| 2610136 | ecrin-mdr-crc

A multicentre, randomised, double-blind, placebo-controlled, dose-finding phase II clinical study to evaluate the efficacy of two different doses of MT-102 administered over a sixteen week period in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer

Project description:Intervention1: MT-102: 1x 2.5mg tablet of MT-102 two times per day 1x 2.5mg tablet of MT-102 + 1 placebo tablet two times per day 1x 2.5mg tablet of MT-102 + 3 placebo tablet two times per day 1 x 2.5mg tablet of MT-102 two times per day 2x 2.5mg tablet of MT-102 two times per day 4 x 2.5mg tablets of MT-102 two times per day Control Intervention1: Placebo: 1x placebo tablet two times per day 2x placebo tablet two times per day 4x placebo tablet two times per day Primary outcome(s): Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week periodTimepoint: Day 7, 14, 21, 28, 56, 84, 112 and 140. Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

| 2572880 | ecrin-mdr-crc

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