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Phase 1 study of CS-7017 in combination with FOLFIRI

ABSTRACT: 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

DISEASE(S): Metastatic Crc Who Failed First-line Therapy

PROVIDER: 100185 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase 1 study of CS-7017 in combination with FOLFIRI

Project description:Intervention name : CS-7017 INN of the intervention : efatutazone Dosage And administration of the intervention : CS-7017(0.25-0.50 mg) administered orally twice a day Control intervention name : null 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

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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

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NK012 phase II clinical study

Project description:Interventions: investigational material(s) Generic name etc : NK012(other antitumor agents) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous

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Safety comformation study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

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Phase I/II study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

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Project description:Interventions: investigational material(s) Generic name etc : Oxaliplatin|Fluorouracil|Levofolinate calcium INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion Primary outcome(s): Safety Study Design: Open-label, multicenter trial

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Project description:Interventions: investigational material(s) Generic name etc : Oxaliplatin | Tegafur-Gimeracil-Oteracil potassium capsule INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oxaliptatin:Infusion, Tegafur-Gimeracil-Oteracil potassium capsule:Oral Primary outcome(s): To determine RD,calculate response rate at the RD Study Design: Open-label,multicenter trial

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