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

ABSTRACT: 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

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2610478 | 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: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 phase I study of TSU-68 in patient with metastatic colorectal cancer

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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

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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.

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

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JCOG1805: Randomized controlled study of adjuvant chemotherapy for stage II colorectal cancer patients at high risk of developing recurrence according to T-stage and three selected pathological factors

Project description:Interventions: A: Observasion (surgely-alone). Patients in this group are observed without any adjuvant chemotherapy. B: Capecitabine for 6 month: Capecitabine (1,250 mg/m2) is orally administered twice daily after meals for 14 days, followed by a 7-day rest. A total of 8 courses are administered C: CAPOX for 3 month: Oxaliplatin (130 mg/m2) is administered intravenously at day 1, and capecitabine (1,000 mg/m2) is orally administered twice daily after meals for 14 days, followed by a 7-day rest. A total of 4 courses are administered. Primary outcome(s): Relapse-free survival (RFS) Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

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

Project description: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

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Gene expression profiling using RNA-Seq data of MMTV-Wnt1 tumor tissue from mice treated with E7386

Project description:We conducted an RNA-Seq analysis using total RNA extracted from MMTV-Wnt1 tumor tissues resected from mice orally administered E7386 at 25 or 50 mg/kg twice daily, or vehicle, for 3 days (Day 4) or 7 days (Day 8) and examined the differentially expressed gene levels compared with vehicle at days 4 and 8.

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