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

ABSTRACT: Interventions: investigational material(s) Generic name etc : TSU-68, S-1, Oxaliplatin INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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 material(s) Generic name etc : S-1, Oxaliplatin INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 100336 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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

Project description:Interventions: investigational material(s) Generic name etc : TSU-68, S-1, Oxaliplatin INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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. TSU-68 is orally administered at 200 mg or 400 mg twice a day after meals on day 1 to 21. Primary outcome(s): Safety (dose limiting toxicity) CTCAE (ver. 3.0) Study Design: Open-label, phase I study

| 100333 | ecrin-mdr-crc

A phase I 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. TSU-68 is orally administered at 200 mg or 400 mg twice a day after meals on day 1 to 21. Control intervention name : null Primary outcome(s): Safety (dose limiting toxicity) CTCAE (ver. 3.0) Study Design: Open-label, phase I study

| 2610478 | 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

A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

Project description:Interventions: investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Generic name etc : L-OHP (Oxaliplatin) INN of investigational material : oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Generic name etc : BV (Bevacizumab) INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks control material(s) Generic name etc : 5-FU (Fluorouracil) INN of investigational material : fluorouracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Generic name etc : l-LV (Levofolinate calcium) INN of investigational material : folic acid Therapeutic category code : 392 Antidotes Dosage and Administration for Investigational material : 200 mg IV on day 1. Repeat cycles every 2 weeks. Generic name etc : L-OHP (Oxaliplatin) INN of investigational material : oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Generic name etc : BV (Bevacizumab) INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

| 97778 | ecrin-mdr-crc

An exploratory study of treatment sensitivity and prognostic factors in a efficacy and safety study of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naive unresectable advanced or recurrent colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : mFOLFOX6 + panitumumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks control material(s) Generic name etc : mFOLFOX6 + bevacizumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

| 97976 | ecrin-mdr-crc

A phase I study of TAS-102 and irinotecan

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| 100929 | ecrin-mdr-crc

Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

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Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (PARADIGM study)

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| 97964 | ecrin-mdr-crc

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

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:Interventions: investigational material(s) Generic name etc : trifluridine/tipiracil INN of investigational material : trifluridine/tipiracil Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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. Generic name etc : bevacizumab INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. control material(s) Generic name etc : fluorouracil INN of investigational material : fluorouracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : [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. Generic name etc : TS-1(tegafur + gimeracil + oteracil potassium) INN of investigational material : TS-1(tegafur + gimeracil + oteracil potassium) Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : [Treatment with TS-1+ irinotecan +bevacizumab (3- Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 98099 | ecrin-mdr-crc

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