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A phase I 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. 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

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 100333 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A phase II 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. 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

| 100336 | 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

RNAseq data on HDAC Class IIa inhibitor (CHDI-00390576) dosed R6/2 mice.

Project description:R6/2 and WT mice treated orally twice a day with vehicle (10% HPβCD), and R6/2 mice treated with either 30 or 100 mg/kg orally twice a day CHDI-00390576. CHDI-00390576 is a Class IIa HDAC inhibitor. Mice were dosed from 4 - 12 weeks of age.

2017-09-23 | GSE104086 | GEO

RNAseq data on HDAC Class IIa inhibitor (CHDI-00390576) dosed Q175 mice.

Project description:WT and Q175 heterozygous (het) mice treated orally twice a day with vehicle (10% HPβCD), and Q175 mice treated with either 30 or 100 mg/kg orally twice a day CHDI-00390576. CHDI-00390576 is a Class IIa HDAC inhibitor. Mice were dosed from 4 weeks to 6 months of age.

2017-09-23 | GSE104064 | GEO

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

Project description:Interventions: investigational material(s) Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin) INN of investigational material : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment. control material(s) Generic name etc : UFT(tegafur + uracil) LV (Folic acid) INN of investigational material : UFT: tegafur, uracil LV:folic acid Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment. Primary outcome(s): efficacy Disease-free survival (DFS) Study Design: Randomized, open-label, comparative study

| 97801 | ecrin-mdr-crc

Phase 1 study of CS-7017 in combination with FOLFIRI

Project description:Interventions: investigational material(s) Generic name etc : CS-7017 INN of investigational material : efatutazone Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : CS-7017(0.25-0.50 mg) administered orally twice a day Primary outcome(s): Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol Study Design: Open Label Phase 1 Study

| 100185 | ecrin-mdr-crc

A Pharmacogenomics Study of TAS-102

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 : 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 material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : 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

| 100784 | 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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